Bayer Healthcare Manufacturing Srl

Registered sites: 13
Drug products: 360
Live patents: 156
Countries: 6
Base: Germany

Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingparticle size reductionRepackagingsterilize

Sites

Facilities

Site	Location	Operations	FEI
Bayer AG	BergkamenGermany	Analytical testing, Active ingredient (API) manufacture	3002808084
Bayer AG	BerlinGermany	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize	3002808086
Bayer Aktiengesellschaft	BerlinGermany	Analytical testing, Packaging, particle size reduction	3002808063
Bayer Bitterfeld GmbH	Bitterfeld-WolfenGermany	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003882513
Bayer AG	LeverkusenGermany	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction	3002806462
Bayer AG	WuppertalGermany	Analytical testing, Active ingredient (API) manufacture, Packaging	3003229486
Bayer Hispania, S.L.	LANGREO/LLANGREUSpain	Active ingredient (API) manufacture	3002988759
Bayer Oy	TurkuFinland	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	1000350927
Bayer Healthcare Manufacturing Srl	Garbagnate-MilaneseItaly	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002806461
Bayer de Mexico, S.A. de C.V.	LermaMexico	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002806479
Bayer HealthCare LLC	Berkeley, CAUnited States	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	2910913
Bayer HealthCare LLC	Morristown, NJUnited States	Finished drug manufacture	2243252
BAYER HEALTHCARE LLC	Myerstown, PAUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging, Repackaging	2510692

Exclusivity

Patents

156

Unexpired Orange Book patents where this company is the application holder.

Product	Active ingredient	Expiry
ADEMPAS	RIOCIGUAT	Dec 2026
ADEMPAS	RIOCIGUAT	Feb 2034
ALIQOPA	COPANLISIB DIHYDROCHLORIDE	Oct 2029
ALIQOPA	COPANLISIB DIHYDROCHLORIDE	Mar 2032
AMBELVIST	GADOQUATRANE	May 2036
AMBELVIST	GADOQUATRANE	Nov 2039
AMBELVIST	GADOQUATRANE	May 2040
ANGELIQ	DROSPIRENONE; ESTRADIOL	Oct 2031
BEYAZ	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	Feb 2030
BEYAZ	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	Jul 2030
HYRNUO	SEVABERTINIB	Oct 2035
HYRNUO	SEVABERTINIB	Nov 2043
KERENDIA	FINERENONE	Aug 2033
KERENDIA	FINERENONE	Jul 2035
KYLEENA	LEVONORGESTREL	Feb 2027
KYLEENA	LEVONORGESTREL	Sept 2029
KYLEENA	LEVONORGESTREL	Sept 2029
LEVITRA	VARDENAFIL HYDROCHLORIDE	Jul 2027
LYNKUET	ELINZANETANT	Sept 2027
LYNKUET	ELINZANETANT	May 2036
LYNKUET	ELINZANETANT	Mar 2039
LYNKUET	ELINZANETANT	May 2045
MIRENA	LEVONORGESTREL	Sept 2029
MIRENA	LEVONORGESTREL	Sept 2029
NATAZIA	DIENOGEST; ESTRADIOL VALERATE	Jan 2028
NEXAVAR	SORAFENIB TOSYLATE	Dec 2027
NEXAVAR	SORAFENIB TOSYLATE	Sept 2028
NUBEQA	DAROLUTAMIDE	Oct 2030
NUBEQA	DAROLUTAMIDE	Mar 2033
NUBEQA	DAROLUTAMIDE	Jan 2036
NUBEQA	DAROLUTAMIDE	Feb 2038
NUBEQA	DAROLUTAMIDE	Jul 2040
NUBEQA	DAROLUTAMIDE	Jun 2042
SAFYRAL	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	Feb 2030
SAFYRAL	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	Jul 2030
SKYLA	LEVONORGESTREL	Feb 2027
SKYLA	LEVONORGESTREL	Sept 2029
SKYLA	LEVONORGESTREL	Sept 2029
STAXYN	VARDENAFIL HYDROCHLORIDE	Dec 2028
STIVARGA	REGORAFENIB	Jun 2030
STIVARGA	REGORAFENIB	Feb 2031
STIVARGA	REGORAFENIB	Apr 2031
STIVARGA	REGORAFENIB	Jul 2032
VITRAKVI	LAROTRECTINIB SULFATE	Oct 2029
VITRAKVI	LAROTRECTINIB SULFATE	Dec 2029
VITRAKVI	LAROTRECTINIB SULFATE	Nov 2035
VITRAKVI	LAROTRECTINIB SULFATE	Aug 2036
VITRAKVI	LAROTRECTINIB SULFATE	Apr 2037
VITRAKVI	LAROTRECTINIB SULFATE	May 2037

Catalogue

Marketed products

360

Showing 150 of 360.

Brand	Generic name	Form	Category
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve	aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate	KIT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels	acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE	POWDER, FOR SOLUTION	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate	KIT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Flu Severe Fast Dissolve	chlorpheniramine maleate, acetaminophen, dextromethorphan hydrobromide	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve	chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels	Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Doxylamine succinate	KIT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride	KIT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels	Acetaminophen, Dextromethorphan hydrobromide , Doxylamine Succinate, Phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Cough Fast	acetaminophen, dextromethorphan hydrobromide	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve	aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve	Aspirin, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate	KIT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Flu Severe Fast Chewables	chlorpheniramine maleate, acetaminophen, dextromethorphan hydrobromide	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE	POWDER, FOR SOLUTION	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve	aspirin, chlorpheniramine maleate, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve Orange	aspirin, chlorpheniramine maleate, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels	Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Doxylamine succinate	KIT	OTC MONOGRAPH DRUG
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels	Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
-	ASP Free Cold and Flu Ni.LF. BLM	CAPSULE	DRUG FOR FURTHER PROCESSING
-	ASP SS CA C LG BLM	CAPSULE	DRUG FOR FURTHER PROCESSING
-	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Guaifenesin	CAPSULE, LIQUID FILLED	DRUG FOR FURTHER PROCESSING
-	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine hydrogen succinate	CAPSULE, LIQUID FILLED	DRUG FOR FURTHER PROCESSING
-	Acetaminophen, Guafenesin	CAPSULE	DRUG FOR FURTHER PROCESSING
-	Acetaminophen, Guafenesin	CAPSULE	DRUG FOR FURTHER PROCESSING
-	Acetaminophen, Phenylephrine, Dextromethorphan Hydrobromide, Doxylamine Succinate	CAPSULE	DRUG FOR FURTHER PROCESSING
Adempas	riociguat	TABLET, FILM COATED	NDA
Adempas	riociguat	TABLET, FILM COATED	NDA
Adempas	riociguat	TABLET, FILM COATED	NDA
Adempas	riociguat	TABLET, FILM COATED	NDA
Adempas	riociguat	TABLET, FILM COATED	NDA
Afrin Allergy Sinus Nasal	oxymetazoline hydrochloride	SPRAY	OTC MONOGRAPH DRUG
Afrin No Drip Extra Moisturizing	Oxymetazoline hydrochloride	SPRAY, METERED	OTC MONOGRAPH DRUG
Afrin No Drip Original Pump Mist	Oxymetazoline hydrochloride	SPRAY, METERED	OTC MONOGRAPH DRUG
Afrin No Drip Pump Mist Bundle Pack	Oxymetazoline hydrochloride	KIT	OTC MONOGRAPH DRUG
Afrin No Drip Severe Congestion	Oxymetazoline hydrochloride	SPRAY, METERED	OTC MONOGRAPH DRUG
Afrin No-Drip Allergy Sinus	Oxymetazoline hydrochloride	SPRAY, METERED	OTC MONOGRAPH DRUG
Afrin NoDrip Allergy Sinus Night	oxymetazoline hydrochloride	SPRAY	OTC MONOGRAPH DRUG
Afrin Original	Oxymetazoline hydrochloride	SPRAY	OTC MONOGRAPH DRUG
Afrin Original Nasal	OXYMETAZOLINE HYDROCHLORIDE	SPRAY	OTC MONOGRAPH DRUG
Afrin Original Pump Mist	Oxymetazoline hydrochloride	SPRAY, METERED	OTC MONOGRAPH DRUG
Afrin Severe Congestion	Oxymetazoline hydrochloride	SPRAY	OTC MONOGRAPH DRUG
Aleve	NAPROXEN SODIUM	TABLET	NDA
Aleve	NAPROXEN SODIUM	TABLET	NDA
Aleve	Naproxen Sodium	CAPSULE, LIQUID FILLED	NDA
Aleve Arthritis Pain Gel	Diclofenac Sodium	GEL	ANDA
Aleve Back and Muscle Pain	NAPROXEN SODIUM	TABLET	NDA
Aleve Back and Muscle Pain	Naproxen Sodium	TABLET	NDA
Aleve Caplets	NAPROXEN SODIUM	TABLET	NDA
Aleve Caplets	NAPROXEN SODIUM	TABLET	NDA
Aleve Caplets - Easy Open Arthritis Cap	NAPROXEN SODIUM	TABLET	NDA
Aleve Caplets Easy Open Arthritis	NAPROXEN SODIUM	TABLET	NDA
Aleve Caplets Soft Grip Arthritis	NAPROXEN SODIUM	TABLET	NDA
Aleve Easy Open Arthritis	NAPROXEN SODIUM	TABLET	NDA
Aleve Easy Open Arthritis Cap	NAPROXEN SODIUM	TABLET	NDA
Aleve Easy Open Arthritis Cap	Naproxen Sodium	CAPSULE, LIQUID FILLED	NDA
Aleve Gelcaps	NAPROXEN SODIUM	TABLET, COATED	NDA
Aleve Gelcaps	NAPROXEN SODIUM	TABLET, COATED	NDA
Aleve Headache Pain	Naproxen Sodium	TABLET	NDA
Aleve Headache Pain	NAPROXEN SODIUM	TABLET	NDA
Aleve Headache Pain	NAPROXEN SODIUM	TABLET	NDA
Aleve PM	DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM	TABLET, FILM COATED	NDA
Aleve liquid gels	Naproxen Sodium	CAPSULE, LIQUID FILLED	ANDA
Aleve-D Sinus and Cold	naproxen sodium, pseudeoephedrine hydrochloride	TABLET	ANDA
Aleve-D Sinus and Headache	naproxen sodium, pseudoephedrine hydrochloride	TABLET	ANDA
AleveX	camphor and menthol	SPRAY	OTC MONOGRAPH DRUG
AleveX	camphor and menthol	LOTION	OTC MONOGRAPH DRUG
AleveX	camphor and menthol	LOTION	OTC MONOGRAPH DRUG
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve	aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
-	Alka Seltzer Plus Free Cold and Flu Day Liqui-Gels	CAPSULE	DRUG FOR FURTHER PROCESSING
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz	dextromethorphan hydrobromide, guaifenesin	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels	Acetaminophen, Dextromethorphan hydrobromide , Doxylamine Succinate, Phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Cool Action Extra Strength ReliefChews Mint	Calcium Carbonate	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Alka-Seltzer Cool Action Heartburn Relief Mint	Calcium Carbonate	GUM, CHEWING	OTC MONOGRAPH DRUG
Alka-Seltzer Extra Strength	Anhydrous Citric Acid, Sodium Bicarbonate, and Aspirin	GRANULE, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Extra Strength Heartburn ReliefChews	Calcium carbonate	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Alka-Seltzer Extra Strength Pain Relief	ANHYDROUS CITRIC ACID, ASPIRIN	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Gold	Alka-Seltzer Gold	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Hangover Relief	ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Heartburn	Anhydrous citric acid, Sodium bicarbonate (heat-treated)	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punch	CALCIUM CARBONATE AND SIMETHICONE	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Alka-Seltzer Heartburn Relief Extra Strength	Anhydrous citric acid, Sodium bicarbonate (heat-treated)	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Heartburn Relief Lemon Lime	Anhydrous citric acid, Sodium bicarbonate (heat-treated)	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Heartburn Relief Peppermint	calcium carbonate	GUM, CHEWING	OTC MONOGRAPH DRUG
Alka-Seltzer Heartburn ReliefChews	CALCIUM CARBONATE	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Alka-Seltzer Heartburn ReliefChews Strawberry and Orange	CALCIUM CARBONATE	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Alka-Seltzer Heartburn and Pain	ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Kids Tummy ReliefChews	calcium carbonate and dimethicone	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Alka-Seltzer Original	ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Original Flavor	Alka-Seltzer Original Flavor	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Pain Relief	Alka-Seltzer Pain Relief	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold Day and Night	Aspirin, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold Day and Night PowerMax gels	Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold Day and Night PowerMax gels	Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold Medicine Sparkling Original	ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold Night	Aspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold Orange Zest	Aspirin, Chlorpheniramine Maleate, Phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold Sparkling Original	Aspirin, Chlorpheniramine maleate, Phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz	aspirin, chlorpheniramine maleate, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold and Cough	Aspirin, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cold and Flu FizzyChews	chlorpheniramine maleate, acetaminophen, dextromethorphan hydrobromide	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cough and Sore Throat FizzyChews	acetaminophen, dextromethorphan hydrobromide	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE	POWDER, FOR SOLUTION	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels	Acetaminophen, Chlorpheniramine malaeate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Day Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels	acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride, doxylamine succinate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Doxylamine succinate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Doxylamine succinate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	acetaminophen, dextrmethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Night Cold and Flu	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz	chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels	Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE	POWDER, FOR SOLUTION	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold PowerFast Fizz	aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy	asprin, dextromethorphan hydrobromide, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest	aspirin, chlorpheniramine maleate, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night	aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz	aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide	TABLET, EFFERVESCENT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride, Guaifenesin	KIT	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels	Alka-Seltzer Plus Severe Cough Mucus and Congestion	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride	CAPSULE, LIQUID FILLED	OTC MONOGRAPH DRUG
Alka-Seltzer Ultra Strength Heartburn ReliefChews	Calcium carbonate	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and Orange	Calcium Carbonate	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Ambelvist	Gadoquatrane	INJECTION	NDA
Ambelvist	Gadoquatrane	INJECTION	NDA
Ambelvist	Gadoquatrane	INJECTION	NDA
Ambelvist	Gadoquatrane	INJECTION	NDA
Ambelvist	Gadoquatrane	INJECTION	NDA
Ambelvist	Gadoquatrane	INJECTION	NDA

Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.