Is AstraZeneca PLC FDA approved?

AstraZeneca PLC holds 15 FDA-registered establishments across 5 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are AstraZeneca PLC's drugs manufactured?

At registered sites in France, the United Kingdom, the Netherlands, Sweden, the United States. The FDA register lists Dunkerque; Liverpool; Macclesfield; Nijmegen; Sodertalje; Bensalem, PA, and 8 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction, relabelling, repackaging.

What drugs does AstraZeneca PLC make?

153 products are listed under AstraZeneca PLC in the openFDA NDC Directory, most often as tablet, film coated; injection, solution; tablet, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

AstraZeneca PLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 15
Active NDC listings: 153
Labeller names: 3
Live patents: 330
Exclusivities: 15
Shortage listings: 2
Countries: 5
Base: United States

Authorisation

Registered operations

Analytical testing13Active ingredient (API) manufacture5Labelling8Finished drug manufacture12Packaging9particle size reduction1Relabelling2Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
AstraZeneca Dunkerque ProductionRegistrant: AstraZeneca PLC	Zone Entree Noord Gracht, 224 Avenue de la Dordogne, Dunkerque, 59640, France (FRA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003063819267941768
MedImmune UK LimitedRegistrant: AstraZeneca PLC	Plot 6 Renaissance Way, Liverpool, L24 9JW, United Kingdom (GBR)	Analytical testing, Active ingredient (API) manufacture	3004066112238627306
AstraZeneca UK LtdRegistrant: AstraZeneca PLC	Silk Road Business Park, Macclesfield, SK10 2NA, United Kingdom (GBR)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002850317232235408
AstraZeneca Nijmegen B.V.Registrant: AstraZeneca PLC	Lagelandseweg 78, Nijmegen, 6545 CG, Netherlands (NLD)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003000472415811041
AstraZeneca ABRegistrant: AstraZeneca PLC	Forskargatan 18, Sodertalje, 151 36, Sweden (SWE)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, Relabelling	3002806411353951254
AstraZeneca ABRegistrant: AstraZeneca PLC	Gartunavagen, Sodertalje, 152 57, Sweden (SWE)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003342394631892705
AstraZeneca Pharmaceuticals LPRegistrant: AstraZeneca PLC	3600 Marshall Ln, Bensalem, Pennsylvania (PA) 19020, United States (USA)	Finished drug manufacture	3014292925876799128
IPR Pharmaceuticals, IncRegistrant: AstraZeneca PLC	Rd 188 Lot 17 San Isidro Industrial Park, Canovanas, Puerto Rico (PR) 00729, United States (USA)	Analytical testing, Finished drug manufacture, Relabelling, Repackaging	3003009422156931248
AstraZeneca Pharmaceuticals LPRegistrant: AstraZeneca PLC	508 Wrangler Drive, Coppell, Texas (TX) 75019-4634, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3010199915081032900
AstraZeneca Pharmaceuticals LPRegistrant: AstraZeneca PLC	633 Research Court, Frederick, Maryland (MD) 21703, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging	3002617771968459953
AstraZeneca Pharmaceuticals LPRegistrant: AstraZeneca PLC	4601 Highway 62 East, Mount Vernon, Indiana (IN) 47620, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1825662938368834
AstraZeneca Pharmaceuticals LPRegistrant: AstraZeneca PLC	587 Old Baltimore Pike, Newark, Delaware (DE) 19702, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	2517100054743190
AstraZeneca Pharmaceuticals LPRegistrant: AstraZeneca PLC	3001 Red Lion Road, Philadelphia, Pennsylvania (PA) 19114, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3004829714830603531
AstraZeneca Pharmaceuticals LPRegistrant: AstraZeneca PLC	200 Cardinal Way, Redwood City, California (CA) 94063, United States (USA)	Analytical testing, Active ingredient (API) manufacture, particle size reduction	3011389428081032904
AstraZeneca Pharmaceuticals LPRegistrant: AstraZeneca PLC	355 Omicron Ct, Shepherdsville, Kentucky (KY) 40165, United States (USA)	Finished drug manufacture	3014798309190578984

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Pramlintide Acetate InjectionEndocrinology/Metabolism	SymlinPen® 60 , Injection, 1000 ug/1 mL (NDC 0310-6615-02)	To Be Discontinued	-	27 Oct 202527 Oct 2025
Pramlintide Acetate InjectionEndocrinology/Metabolism	SymlinPen® 120 , Injection, 1000 ug/1 mL (NDC 0310-6627-02)	To Be Discontinued	-	27 Oct 202527 Oct 2025

Catalogue

Drug listings by form and route

153

153 active NDC listings: 83 human prescription drug, 54 drug for further processing, 16 bulk ingredient. By marketing category: NDA 71, DRUG FOR FURTHER PROCESSING 54, BULK INGREDIENT 16, BLA 10, NDA AUTHORIZED GENERIC 2.

Dosage form	NDCs
tablet, film coated	45
injection, solution	14
tablet, extended release	13
tablet	12
tablet, film coated, extended release	10
liquid	7
powder	7
capsule	6
capsule, delayed release	5
granule, delayed release	5
injection	5
aerosol	4
aerosol, metered	4
powder, for suspension	3
suspension	3

Route	NDCs
oral	55
respiratory (inhalation)	11
subcutaneous	10
intravenous	6
intramuscular	1

Labeller name on the listing	NDCs
astrazeneca pharmaceuticals lp	112
astrazeneca ab	39
astrazeneca uk limited	2

Exclusivity

Patents and exclusivities

330

Patent	Product	Covers	Expiry
7459554	CALQUENCEacalabrutinib; acalabrutinib maleate	substance	Nov 2026
9156795	KOSELUGOselumetinib sulfate	substance, product	Dec 2026
9562017	KOSELUGOselumetinib sulfate	substance	Dec 2026
7960370	EPANOVAomega-3-carboxylic acids	product	Dec 2026
8329648*PED	BYDUREON, BYDUREON BCISE, BYDUREON PEN, FARXIGAdapagliflozin; exenatide synthetic	use	Feb 2027
8906851*PED	BYDUREON, BYDUREON BCISE, BYDUREON PEN, FARXIGAdapagliflozin; exenatide synthetic	use	Feb 2027
9884092*PED	BYDUREON, BYDUREON BCISE, BYDUREON PENexenatide synthetic	use	Feb 2027
8501698	BYDUREON, BYDUREON BCISE, BYDUREON PEN, FARXIGA, QTERN, QTERNMET XR, XIGDUO XRdapagliflozin; dapagliflozin; metformin hydrochloride; dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride; dapagliflozin; saxagliptin hydrochloride; exenatide synthetic	product	Jun 2027
8071579	LYNPARZAolaparib	use	Aug 2027
8143241	LYNPARZAolaparib	use	Aug 2027
7449464	LYNPARZAolaparib	substance, product	Sept 2027
8501698*PED	BYDUREON, BYDUREON BCISE, BYDUREON PEN, FARXIGA, QTERN, QTERNMET XR, XIGDUO XRdapagliflozin; dapagliflozin; metformin hydrochloride; dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride; dapagliflozin; saxagliptin hydrochloride; exenatide synthetic	use	Dec 2027
7425637	KOSELUGOselumetinib sulfate	substance	Mar 2028
8221786	FARXIGA, QTERNdapagliflozin; dapagliflozin; saxagliptin hydrochloride	product	Mar 2028
8361972	BYDUREON, BYDUREON BCISE, BYDUREON PEN, FARXIGA, QTERNdapagliflozin; dapagliflozin; saxagliptin hydrochloride; exenatide synthetic	use	Mar 2028
8716251	FARXIGA, QTERN, QTERNMET XRdapagliflozin; dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride; dapagliflozin; saxagliptin hydrochloride	product	Mar 2028
7851502	FARXIGAdapagliflozin	product	Aug 2028
8221786*PED	FARXIGA, QTERNdapagliflozin; dapagliflozin; saxagliptin hydrochloride	use	Sept 2028
8361972*PED	BYDUREON, BYDUREON BCISE, BYDUREON PEN, FARXIGA, QTERNdapagliflozin; dapagliflozin; saxagliptin hydrochloride; exenatide synthetic	use	Sept 2028
8716251*PED	FARXIGA, QTERN, QTERNMET XRdapagliflozin; dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride; dapagliflozin; saxagliptin hydrochloride	use	Sept 2028
8247416	LYNPARZAolaparib	substance	Sept 2028
10059714	TRUQAPcapivasertib	substance, product	Oct 2028
10654855	TRUQAPcapivasertib	use	Oct 2028
11236095	TRUQAPcapivasertib	use	Oct 2028
11760760	TRUQAPcapivasertib	use	Oct 2028
12252495	TRUQAPcapivasertib	use	Oct 2028
9492453	TRUQAPcapivasertib	use	Oct 2028
7951400	ONGLYZAsaxagliptin hydrochloride	product	Nov 2028
7851502*PED	FARXIGAdapagliflozin	use	Feb 2029
11813246	KOSELUGOselumetinib sulfate	product	Mar 2029
12220403	KOSELUGOselumetinib sulfate	product	Mar 2029
12318367	KOSELUGOselumetinib sulfate	product	Mar 2029
12364684	KOSELUGOselumetinib sulfate	use	Mar 2029
11633396	LYNPARZAolaparib	product	Oct 2029
11975001	LYNPARZAolaparib	product	Oct 2029
12048695	LYNPARZAolaparib	product	Oct 2029
12144810	LYNPARZAolaparib	product	Oct 2029
12178816	LYNPARZAolaparib	product	Oct 2029
7919598	FARXIGA, QTERN, QTERNMET XR, XIGDUO XRdapagliflozin; dapagliflozin; metformin hydrochloride; dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride; dapagliflozin; saxagliptin hydrochloride	substance	Dec 2029
8475842	LYNPARZAolaparib	product	Dec 2029
8101623	TRUQAPcapivasertib	substance, product	Mar 2030
8425934	BRILINTAticagrelor	product	Apr 2030
8685934	FARXIGA, XIGDUO XRdapagliflozin; dapagliflozin; metformin hydrochloride	use	May 2030
10716753	BEVESPI AEROSPHERE, BREZTRI AEROSPHERE, SYMBICORT AEROSPHEREbudesonide; formoterol fumarate; budesonide; formoterol fumarate; glycopyrrolate; formoterol fumarate; glycopyrrolate	product	May 2030
8324266	BEVESPI AEROSPHERE, BREZTRI AEROSPHEREbudesonide; formoterol fumarate; glycopyrrolate; formoterol fumarate; glycopyrrolate	use	May 2030
8703806	BEVESPI AEROSPHERE, BREZTRI AEROSPHEREbudesonide; formoterol fumarate; glycopyrrolate; formoterol fumarate; glycopyrrolate	use	May 2030
8808713	BEVESPI AEROSPHERE, BREZTRI AEROSPHEREbudesonide; formoterol fumarate; glycopyrrolate; formoterol fumarate; glycopyrrolate	product	May 2030
9415009	AIRSUPRA, BEVESPI AEROSPHERE, BREZTRI AEROSPHERE, SYMBICORT AEROSPHEREalbuterol sulfate; budesonide; budesonide; formoterol fumarate; budesonide; formoterol fumarate; glycopyrrolate; formoterol fumarate; glycopyrrolate	use	May 2030
9463161	BEVESPI AEROSPHERE, BREZTRI AEROSPHEREbudesonide; formoterol fumarate; glycopyrrolate; formoterol fumarate; glycopyrrolate	product	May 2030
7919598*PED	FARXIGA, QTERN, QTERNMET XR, XIGDUO XRdapagliflozin; dapagliflozin; metformin hydrochloride; dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride; dapagliflozin; saxagliptin hydrochloride	use	Jun 2030
8721615*PED	FARXIGAdapagliflozin	use	Jul 2030
8895033	BYDUREON BCISEexenatide synthetic	product	Oct 2030
8425934*PED	BRILINTAticagrelor	use	Oct 2030
9616028	QTERNMET XR, XIGDUO XRdapagliflozin; metformin hydrochloride; dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	product	Nov 2030
8685934*PED	FARXIGA, XIGDUO XRdapagliflozin; dapagliflozin; metformin hydrochloride	use	Nov 2030
8815258	BEVESPI AEROSPHERE, BREZTRI AEROSPHEREbudesonide; formoterol fumarate; glycopyrrolate; formoterol fumarate; glycopyrrolate	use	Mar 2031
8895033*PED	BYDUREON BCISEexenatide synthetic	use	Apr 2031
9616028*PED	QTERNMET XR, XIGDUO XRdapagliflozin; metformin hydrochloride; dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	use	May 2031
8859562	LYNPARZAolaparib	use	Aug 2031
10335432	LOKELMAsodium zirconium cyclosilicate	use	Feb 2032

Product	Exclusivity	Until
AIRSUPRAALBUTEROL SULFATE; BUDESONIDE	M-317 Miscellaneous	Sept 2028
BAXFENDYBAXDROSTAT	NCE New chemical entity	May 2031
BREZTRI AEROSPHEREBUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	NS New strength	Apr 2029
CALQUENCEACALABRUTINIB	D-200 New dosing schedule	Feb 2029
FARXIGADAPAGLIFLOZIN	PED Paediatric	Dec 2027
KOSELUGOSELUMETINIB SULFATE	ODE* Orphan drug	Nov 2032
KOSELUGOSELUMETINIB SULFATE	ODE-545 Orphan drug	Nov 2032
LYNPARZAOLAPARIB	ODE-306 Orphan drug	May 2027
ONGLYZASAXAGLIPTIN HYDROCHLORIDE	M-14 Miscellaneous	Oct 2027
SYMBICORT AEROSPHEREBUDESONIDE; FORMOTEROL FUMARATE	I-988 New indication	Apr 2029
SYMBICORT AEROSPHEREBUDESONIDE; FORMOTEROL FUMARATE	NS New strength	Apr 2029
TAGRISSOOSIMERTINIB MESYLATE	ODE-337 Orphan drug	Dec 2027
TRUQAPCAPIVASERTIB	I-991 New indication	Jun 2029
WAINUA (AUTOINJECTOR)EPLONTERSEN SODIUM	ODE-461 Orphan drug	Dec 2030
XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	PED Paediatric	Dec 2027

Catalogue

Marketed products

153

Showing 150 of 153.

Brand	Generic name	Form / route	NDC
AIRSUPRA	Albuterol sulfate and budesonide	aerosol, metered, respiratory (inhalation)	0310-9080NDA
ANDEXXA	andexanet alfa	injection, powder, lyophilized, for solution, intravenous	0310-3200BLA
-	Albuterol Sulfate Micronised Conditioned	powder	17228-9600BULK INGREDIENT
-	Anastrozole	tablet	0310-0201DRUG FOR FURTHER PROCESSING
BAXFENDY	baxdrostat	tablet, film coated, oral	0310-6001NDA
BAXFENDY	baxdrostat	tablet, film coated, oral	0310-6002NDA
BEVESPI AEROSPHERE	Glycopyrrolate and formoterol fumarate	aerosol, metered, respiratory (inhalation)	0310-4600NDA
BREZTRI	budesonide, glycopyrrolate, and formoterol fumarate	aerosol, metered, respiratory (inhalation)	0310-4616NDA
BREZTRI	budesonide, glycopyrrolate, and formoterol fumarate	aerosol, metered, respiratory (inhalation)	0310-6616NDA
BRILINTA	Ticagrelor	tablet, oral	0186-0776NDA
BRILINTA	Ticagrelor	tablet, oral	0186-0777NDA
-	Benralizumab	injection, solution	17228-2730DRUG FOR FURTHER PROCESSING
-	Budesonide Micronised Co-Suspension APN	powder	17228-9700BULK INGREDIENT
-	Budesonide Micronized	powder	17228-1991BULK INGREDIENT
Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	aerosol, respiratory (inhalation)	0310-7370NDA AUTHORIZED GENERIC
Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	aerosol, respiratory (inhalation)	0310-7372NDA AUTHORIZED GENERIC
Byetta	exenatide	injection, subcutaneous	0310-6512NDA
Byetta	exenatide	injection, subcutaneous	0310-6524NDA
CALQUENCE	Acalabrutinib	capsule, gelatin coated, oral	0310-0512NDA
CALQUENCE	acalabrutinib	tablet, film coated, oral	0310-3512NDA
CALQUENCE	acalabrutinib	tablet, film coated, oral	0310-4513NDA
Crestor	Rosuvastatin	tablet, film coated, oral	0310-7560NDA
Crestor	Rosuvastatin	tablet, film coated, oral	0310-7570NDA
Crestor	Rosuvastatin	tablet, film coated, oral	0310-7580NDA
Crestor	Rosuvastatin	tablet, film coated, oral	0310-7590NDA
-	DAPAGLIFLOZIN	tablet, film coated	0310-8205DRUG FOR FURTHER PROCESSING
-	DAPAGLIFLOZIN	tablet, film coated	0310-8210DRUG FOR FURTHER PROCESSING
-	DAPAGLIFLOZIN	tablet, film coated	17228-6205DRUG FOR FURTHER PROCESSING
-	DAPAGLIFLOZIN	tablet, film coated	17228-6210DRUG FOR FURTHER PROCESSING
Daliresp	roflumilast	tablet, oral	0310-0088NDA
Daliresp	roflumilast	tablet, oral	0310-0095NDA
-	Durvalumab	injection, solution	17228-4500DRUG FOR FURTHER PROCESSING
-	Durvalumab	injection, solution	17228-4611DRUG FOR FURTHER PROCESSING
ETCAMAH	camizestrant	tablet, film coated, oral	0310-0075NDA
FARXIGA	DAPAGLIFLOZIN	tablet, film coated, oral	0310-6205NDA
FARXIGA	DAPAGLIFLOZIN	tablet, film coated, oral	0310-6210NDA
FASENRA	Benralizumab	injection, solution, subcutaneous	0310-1730BLA
FASENRA	Benralizumab	injection, solution, subcutaneous	0310-1745BLA
FASENRA	Benralizumab	injection, solution, subcutaneous	0310-1830BLA
FASLODEX	Fulvestrant	injection, intramuscular	0310-0720NDA
-	Goserelin acetate	implant	60440-0960DRUG FOR FURTHER PROCESSING
IMFINZI	Durvalumab	injection, solution, intravenous	0310-4500BLA
IMFINZI	Durvalumab	injection, solution, intravenous	0310-4611BLA
IMJUDO	tremelimumab	injection, solution, intravenous	0310-4505BLA
IMJUDO	tremelimumab	injection, solution, intravenous	0310-4535BLA
IRESSA	Gefitinib	tablet, coated, oral	0310-0482NDA
KOSELUGO	SELUMETINIB	capsule, oral	0310-0610NDA
KOSELUGO	SELUMETINIB	capsule, oral	0310-0625NDA
KOSELUGO	SELUMETINIB	granule, oral	0310-0635NDA
KOSELUGO	SELUMETINIB	granule, oral	0310-0640NDA
LOKELMA	sodium zirconium cyclosilicate	powder, for suspension, oral	0310-1105NDA
LOKELMA	sodium zirconium cyclosilicate	powder, for suspension, oral	0310-1110NDA
Lynparza	olaparib	tablet, film coated, oral	0310-0569NDA
Lynparza	olaparib	tablet, film coated, oral	0310-0578NDA
Lynparza	olaparib	tablet, film coated, oral	0310-0668NDA
Lynparza	olaparib	tablet, film coated, oral	0310-0679NDA
-	Metoprolol succinate	tablet, extended release	17228-0109DRUG FOR FURTHER PROCESSING
-	Metoprolol succinate	tablet, extended release	17228-0110DRUG FOR FURTHER PROCESSING
-	Metoprolol succinate	tablet, extended release	17228-0111DRUG FOR FURTHER PROCESSING
-	Metoprolol succinate	tablet, extended release	17228-1088DRUG FOR FURTHER PROCESSING
-	Micronized Glycopyrronium Bromide	powder	0310-0561BULK INGREDIENT
-	Micronized Glycopyrronium Bromide	powder	17228-4610BULK INGREDIENT
-	Micronized Glycopyrronium Bromide	powder	17228-5600BULK INGREDIENT
-	Monalizumab	liquid	0310-3333BULK INGREDIENT
NEXIUM	Esomeprazole magnesium	granule, delayed release, oral	0186-4010NDA
NEXIUM	Esomeprazole magnesium	granule, delayed release, oral	0186-4020NDA
NEXIUM	Esomeprazole magnesium	granule, delayed release, oral	0186-4025NDA
NEXIUM	Esomeprazole magnesium	granule, delayed release, oral	0186-4040NDA
NEXIUM	Esomeprazole magnesium	granule, delayed release, oral	0186-4050NDA
NEXIUM	Esomeprazole magnesium	capsule, delayed release, oral	0186-5020NDA
NEXIUM	Esomeprazole magnesium	capsule, delayed release, oral	0186-5040NDA
-	Oleclumab	liquid	0310-4141BULK INGREDIENT
-	Omeprazole magnesium	capsule, delayed release	0186-0606DRUG FOR FURTHER PROCESSING
-	Omeprazole magnesium	capsule, delayed release	0186-0742DRUG FOR FURTHER PROCESSING
-	Omeprazole magnesium	capsule, delayed release	0186-0743DRUG FOR FURTHER PROCESSING
-	Omeprazole magnesium	tablet, delayed release	17228-0740DRUG FOR FURTHER PROCESSING
-	Osimertinib	tablet, film coated	0310-1353DRUG FOR FURTHER PROCESSING
-	Osimertinib	tablet, film coated	0310-1354DRUG FOR FURTHER PROCESSING
-	Osimertinib	tablet, film coated	17228-1349DRUG FOR FURTHER PROCESSING
-	Osimertinib	tablet, film coated	17228-1350DRUG FOR FURTHER PROCESSING
PULMICORT RESPULES	Budesonide	suspension, respiratory (inhalation)	0186-1988NDA
PULMICORT RESPULES	Budesonide	suspension, respiratory (inhalation)	0186-1989NDA
PULMICORT RESPULES	Budesonide	suspension, respiratory (inhalation)	0186-1990NDA
-	Rilvegostomig	liquid	0310-9700BULK INGREDIENT
SAPHNELO	Anifrolumab-fnia	injection, solution, intravenous	0310-3040BLA
SAPHNELO	Anifrolumab-fnia	injection, solution, subcutaneous	0310-3080BLA
SEROQUEL	quetiapine	tablet, film coated, oral	0310-0271NDA
SEROQUEL	quetiapine	tablet, film coated, oral	0310-0272NDA
SEROQUEL	quetiapine	tablet, film coated, oral	0310-0274NDA
SEROQUEL	quetiapine	tablet, film coated, oral	0310-0275NDA
SEROQUEL	quetiapine	tablet, film coated, oral	0310-0278NDA
SEROQUEL	quetiapine	tablet, film coated, oral	0310-0279NDA
SEROQUEL XR	quetiapine	tablet, extended release, oral	0310-0281NDA
SEROQUEL XR	quetiapine	tablet, extended release, oral	0310-0282NDA
SEROQUEL XR	quetiapine	tablet, extended release, oral	0310-0283NDA
SEROQUEL XR	quetiapine	tablet, extended release, oral	0310-0284NDA
SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	aerosol, respiratory (inhalation)	0186-0370NDA
SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	aerosol, respiratory (inhalation)	0186-0372NDA
-	Selumetinib	capsule	17228-0635DRUG FOR FURTHER PROCESSING
-	Selumetinib	capsule	17228-0640DRUG FOR FURTHER PROCESSING
-	Sodium Zirconium Cyclosilicate	powder, for suspension	0310-2111BULK INGREDIENT
SymlinPen	pramlintide acetate	injection, subcutaneous	0310-6615NDA
SymlinPen	pramlintide acetate	injection, subcutaneous	0310-6627NDA
TAGRISSO	osimertinib	tablet, film coated, oral	0310-1248NDA
TAGRISSO	osimertinib	tablet, film coated, oral	0310-1251NDA
TAGRISSO	osimertinib	tablet, film coated, oral	0310-1349NDA
TAGRISSO	osimertinib	tablet, film coated, oral	0310-1350NDA
TRUQAP	capivasertib	tablet, film coated, oral	0310-9500NDA
TRUQAP	capivasertib	tablet, film coated, oral	0310-9501NDA
-	Ticagrelor	tablet, film coated	17228-0776DRUG FOR FURTHER PROCESSING
-	Ticagrelor	tablet, film coated	17228-0777DRUG FOR FURTHER PROCESSING
-	Tozorakimab	liquid	0310-2021BULK INGREDIENT
WAINUA	EPLONTERSEN	injection, solution, subcutaneous	0310-9400NDA
WAINUA	EPLONTERSEN	injection, solution, subcutaneous	0310-9420NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release, oral	0310-6225NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release, oral	0310-6250NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release, oral	0310-6260NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release, oral	0310-6270NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release, oral	0310-6280NDA
-	acalabrutinib	tablet, film coated	0310-5512DRUG FOR FURTHER PROCESSING
-	acalabrutinib	tablet, film coated	17228-4512DRUG FOR FURTHER PROCESSING
-	anifrolumab	solution	0310-3000BULK INGREDIENT
-	baxdrostat	tablet, film coated	17228-6001DRUG FOR FURTHER PROCESSING
-	baxdrostat	tablet, film coated	17228-6002DRUG FOR FURTHER PROCESSING
-	benralizumab	liquid	0310-2830BULK INGREDIENT
-	candesartan cilexetil	tablet	17228-0016DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil	tablet	17228-0017DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil	tablet	17228-0018DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil	tablet	17228-0032DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil hydrochlorothiazide	tablet	17228-0162DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil hydrochlorothiazide	tablet	17228-0322DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil hydrochlorothiazide	tablet	17228-0324DRUG FOR FURTHER PROCESSING
-	capivasertib	tablet, film coated	17228-9500DRUG FOR FURTHER PROCESSING
-	capivasertib	tablet, film coated	17228-9501DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release	0310-6325DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release	0310-6350DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release	0310-6360DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release	0310-6370DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	tablet, film coated, extended release	0310-6380DRUG FOR FURTHER PROCESSING
-	durvalumab	liquid	0310-5500BULK INGREDIENT
-	esomeprazole magnesium	capsule	17228-5020DRUG FOR FURTHER PROCESSING
-	esomeprazole magnesium	capsule	17228-5040DRUG FOR FURTHER PROCESSING
-	goserelin implant	implant	60440-0961DRUG FOR FURTHER PROCESSING
-	olaparib	tablet, film coated	17228-0668DRUG FOR FURTHER PROCESSING
-	olaparib	tablet, film coated	17228-0679DRUG FOR FURTHER PROCESSING
-	omeprazole magnesium	tablet, delayed release	17228-0750DRUG FOR FURTHER PROCESSING
-	palivizumab	liquid	0310-4113BULK INGREDIENT
-	quetiapine	tablet, extended release	0310-0505DRUG FOR FURTHER PROCESSING
-	quetiapine	tablet, extended release	0310-0515DRUG FOR FURTHER PROCESSING
-	quetiapine	tablet, extended release	0310-0520DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is AstraZeneca PLC FDA approved?: AstraZeneca PLC holds 15 FDA-registered establishments across 5 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are AstraZeneca PLC's drugs manufactured?: At registered sites in France, the United Kingdom, the Netherlands, Sweden, the United States. The FDA register lists Dunkerque; Liverpool; Macclesfield; Nijmegen; Sodertalje; Bensalem, PA, and 8 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction, relabelling, repackaging.
What drugs does AstraZeneca PLC make?: 153 products are listed under AstraZeneca PLC in the openFDA NDC Directory, most often as tablet, film coated; injection, solution; tablet, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.