Register entry

Mylan Pharmaceuticals, Inc.

Data as of · How to read this entry

Registered sites
0
Active NDC listings
482
Labeller names
4
Live patents
13
Countries
0
Catalogue

Drug listings by form and route

482

482 active NDC listings: 455 human prescription drug, 22 bulk ingredient, 3 human otc drug, 2 drug for further processing. By marketing category: ANDA 361, NDA AUTHORIZED GENERIC 90, BULK INGREDIENT 21, NDA 6, DRUG FOR FURTHER PROCESSING 3.

Dosage formNDCs
tablet126
tablet, film coated125
capsule46
patch40
powder24
cream13
solution13
kit12
capsule, extended release10
tablet, film coated, extended release10
tablet, extended release8
capsule, delayed release pellets6
gel5
tablet, delayed release5
film4
RouteNDCs
oral355
transdermal40
topical19
respiratory (inhalation)15
sublingual7
ophthalmic5
buccal4
subcutaneous2
vaginal2
nasal1
Labeller name on the listingNDCs
mylan pharmaceuticals inc.456
mylan laboratories limited19
mylan pharmaceuticals, inc.4
mylan laboratories limited3
Exclusivity

Patents and exclusivities

13
PatentProductCoversExpiry
7645801SFROWASAmesalaminesubstance, productJul 2027
8147852VUSIONmiconazole nitrate; white petrolatum; zinc oxideuseMar 2028
7288657YUPELRIrevefenacinsubstanceOct 2028
10550081YUPELRIrevefenacinsubstanceJul 2030
11008289YUPELRIrevefenacinuseJul 2030
11691948YUPELRIrevefenacinproductJul 2030
11858898YUPELRIrevefenacinsubstance, productJul 2030
9765028YUPELRIrevefenacinsubstanceJul 2030
8541451YUPELRIrevefenacinsubstanceAug 2031
9345772ERMEZAlevothyroxine sodiumproductFeb 2035
12048692YUPELRIrevefenacinuseAug 2039
12285417YUPELRIrevefenacinuseAug 2039
11484531YUPELRIrevefenacinuseOct 2039
Catalogue

Marketed products

489

Showing 150 of 489.

BrandGeneric nameForm / routeNDC
AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTANtablet, film coated, oral0378-1721ANDA
AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTANtablet, film coated, oral0378-1722ANDA
AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTANtablet, film coated, oral0378-1723ANDA
AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTANtablet, film coated, oral0378-1724ANDA
-ATORVASTATIN CALCIUMgranule65015-282DRUG FOR FURTHER PROCESSING
Abacavir Sulfateabacavir sulfatetablet, film coated, oral0378-4105ANDA
Abiraterone Acetateabiraterone acetatetablet, oral0378-6920ANDA
Abiraterone Acetateabiraterone acetatetablet, film coated, oral0378-6921ANDA
Acamprosate Calciumacamprosate calcium enteric-coatedtablet, delayed release, oral0378-6333ANDA
Acitretinacitretincapsule, oral0378-7020ANDA
Acitretinacitretincapsule, oral0378-7023ANDA
AlbuterolAlbuterolsolution, respiratory (inhalation)0378-7057ANDA
AlbuterolAlbuterolsolution, respiratory (inhalation)0378-7058ANDA
Albuterol SulfateAlbuterol Sulfatesolution, respiratory (inhalation)0378-8270ANDA
Allopurinolallopurinoltablet, oral0378-0137ANDA
Allopurinolallopurinoltablet, oral0378-0181ANDA
Almotriptan MalateAlmotriptantablet, film coated, oral0378-5245ANDA
Almotriptan MalateAlmotriptantablet, film coated, oral0378-5246ANDA
Alprazolamalprazolamtablet, oral59762-3719NDA AUTHORIZED GENERIC
Alprazolamalprazolamtablet, oral59762-3720NDA AUTHORIZED GENERIC
Alprazolamalprazolamtablet, oral59762-3721NDA AUTHORIZED GENERIC
Alprazolamalprazolamtablet, oral59762-3722NDA AUTHORIZED GENERIC
Alprazolam XRalprazolamtablet, extended release, oral59762-0057NDA AUTHORIZED GENERIC
Alprazolam XRalprazolamtablet, extended release, oral59762-0059NDA AUTHORIZED GENERIC
Alprazolam XRalprazolamtablet, extended release, oral59762-0066NDA AUTHORIZED GENERIC
Alprazolam XRalprazolamtablet, extended release, oral59762-0068NDA AUTHORIZED GENERIC
Ambrisentanambrisentantablet, film coated, oral0378-4270ANDA
Ambrisentanambrisentantablet, film coated, oral0378-4271ANDA
Amlodipine and atorvastatinAmlodipine and atorvastatintablet, film coated, oral0378-4513ANDA
Amlodipine and atorvastatinAmlodipine and atorvastatintablet, film coated, oral0378-4514ANDA
Amlodipine and atorvastatinAmlodipine and atorvastatintablet, film coated, oral0378-4515ANDA
Amlodipine and atorvastatinAmlodipine and atorvastatintablet, film coated, oral0378-4516ANDA
Amlodipine and atorvastatinAmlodipine and atorvastatintablet, film coated, oral0378-4517ANDA
Amlodipine and atorvastatinAmlodipine and atorvastatintablet, film coated, oral0378-4518ANDA
Amlodipine and atorvastatinAmlodipine and atorvastatintablet, film coated, oral0378-4519ANDA
Amlodipine and atorvastatinAmlodipine and atorvastatintablet, film coated, oral0378-4520ANDA
Amnesteemisotretinoincapsule, oral0378-6611ANDA
Amnesteemisotretinoincapsule, oral0378-6612ANDA
Amnesteemisotretinoincapsule, oral0378-6613ANDA
Amnesteemisotretinoincapsule, oral0378-6614ANDA
Armodafinilarmodafiniltablet, oral0378-3431ANDA
Armodafinilarmodafiniltablet, oral0378-3432ANDA
Armodafinilarmodafiniltablet, oral0378-3433ANDA
Atenololatenololtablet, oral0378-0218ANDA
Atenololatenololtablet, oral0378-0231ANDA
Atenololatenololtablet, oral0378-0757ANDA
Atorvastatin Calciumatorvastatin calciumtablet, film coated, oral0378-3950ANDA
Atorvastatin Calciumatorvastatin calciumtablet, film coated, oral0378-3951ANDA
Atorvastatin Calciumatorvastatin calciumtablet, film coated, oral0378-3952ANDA
Atorvastatin Calciumatorvastatin calciumtablet, film coated, oral0378-3953ANDA
Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochloridetablet, film coated, oral0378-4160ANDA
Atovaquone and Proguanil Hydrochlorideatovaquone and proguanil hydrochloridetablet, film coated, oral0378-4162ANDA
Azelastine Hydrochloride and Fluticasone PropionateAzelastine Hydrochloride and Fluticasone Propionatespray, metered, nasal0378-3458NDA AUTHORIZED GENERIC
-BOSENTANpowder65015-770BULK INGREDIENT
BREYNABudesonide and Formoterol Fumarateaerosol, metered, respiratory (inhalation)0378-7502ANDA
BREYNABudesonide and Formoterol Fumarateaerosol, metered, respiratory (inhalation)0378-7503ANDA
Bepotastine BesilateBepotastine Besilatesolution/ drops, ophthalmic0378-7055ANDA
BexaroteneBexarotenecapsule, liquid filled, oral0378-6955ANDA
Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazidetablet, film coated, oral0378-0501ANDA
Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazidetablet, film coated, oral0378-0503ANDA
Bisoprolol Fumarate and Hydrochlorothiazidebisoprolol fumarate and hydrochlorothiazidetablet, film coated, oral0378-0505ANDA
Bromocriptine Mesylatebromocriptine mesylatecapsule, oral0378-7096ANDA
BudesonideBudesonidetablet, film coated, extended release, oral0378-4500ANDA
Buprenorphine and NaloxoneBuprenorphine and Naloxonefilm, buccal, sublingual0378-8765ANDA
Buprenorphine and NaloxoneBuprenorphine and Naloxonefilm, buccal, sublingual0378-8766ANDA
Buprenorphine and NaloxoneBuprenorphine and Naloxonefilm, buccal, sublingual0378-8767ANDA
Buprenorphine and NaloxoneBuprenorphine and Naloxonefilm, buccal, sublingual0378-8768ANDA
Buspirone Hydrochloridebuspirone hydrochloridetablet, oral0378-1140ANDA
Buspirone Hydrochloridebuspirone hydrochloridetablet, oral0378-1150ANDA
Buspirone Hydrochloridebuspirone hydrochloridetablet, oral0378-1165ANDA
Buspirone Hydrochloridebuspirone hydrochloridetablet, oral0378-1175ANDA
-CARVEDILOL PHOSPHATEpowder65015-884BULK INGREDIENT
Cabergolinecabergolinetablet, oral59762-1005NDA AUTHORIZED GENERIC
Candesartan Cilexetil and Hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazidetablet, oral0378-3001ANDA
Carbidopa and Levodopacarbidopa and levodopatablet, extended release, oral0378-0088ANDA
Carbidopa and Levodopacarbidopa and levodopatablet, extended release, oral0378-0094ANDA
Carisoprodolcarisoprodoltablet, oral51525-5901NDA AUTHORIZED GENERIC
Cetirizine Hydrochloridecetirizine hydrochloridetablet, film coated, oral0378-3635ANDA
Cetirizine Hydrochloridecetirizine hydrochloridetablet, film coated, oral0378-3637ANDA
Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochloridetablet, film coated, oral0378-0211ANDA
Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochloridetablet, film coated, oral0378-0277ANDA
Chlorthalidonechlorthalidonetablet, oral0378-0213ANDA
Chlorthalidonechlorthalidonetablet, oral0378-0222ANDA
Cimetidinecimetidinetablet, film coated, oral0378-0053ANDA
Cimetidinecimetidinetablet, film coated, oral0378-0317ANDA
Cimetidinecimetidinetablet, film coated, oral0378-0372ANDA
Cimetidinecimetidinetablet, film coated, oral0378-0541ANDA
Citalopramcitalopramtablet, film coated, oral0378-6231ANDA
Citalopramcitalopramtablet, film coated, oral0378-6232ANDA
Citalopramcitalopramtablet, film coated, oral0378-6233ANDA
Clindamycin Phosphate and Benzoyl Peroxideclindamycin phosphate and benzoyl peroxidekit0378-8688ANDA
Clonidineclonidinepatch, transdermal0378-0871ANDA
Clonidineclonidinepatch, transdermal0378-0872ANDA
Clonidineclonidinepatch, transdermal0378-0873ANDA
Clozapineclozapinetablet, oral0378-0825ANDA
Clozapineclozapinetablet, oral0378-0860ANDA
Clozapineclozapinetablet, oral0378-0972ANDA
Clozapineclozapinetablet, oral0378-0973ANDA
Clozapineclozapinetablet, orally disintegrating, oral0378-3813ANDA
Clozapineclozapinetablet, orally disintegrating, oral0378-3815ANDA
Clozapineclozapinetablet, orally disintegrating, oral0378-3816ANDA
Clozapineclozapinetablet, orally disintegrating, oral0378-3817ANDA
ColchicineColchicinetablet, film coated, oral0378-1086ANDA
Colestipol HydrochlorideColestipol Hydrochloridegranule, for suspension, oral59762-0260NDA AUTHORIZED GENERIC
Colestipol HydrochlorideColestipol Hydrochloridetablet, oral59762-0450NDA AUTHORIZED GENERIC
Cyclosporinecyclosporineemulsion, ophthalmic0378-8760ANDA
Cystagoncysteamine bitartratecapsule, oral0378-9040NDA
Cystagoncysteamine bitartratecapsule, oral0378-9045NDA
DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLdesogestrel and ethinyl estradiol and ethinyl estradiolkit0378-7296ANDA
-DIMETHYL FUMARATEpowder65015-844BULK INGREDIENT
DROSPIRENONE AND ETHINYL ESTRADIOLdrospirenone and ethinyl estradiolkit0378-7300ANDA
Dabigatran EtexilateDabigatran Etexilatecapsule, oral0378-0265ANDA
Dabigatran EtexilateDabigatran Etexilatecapsule, oral0378-0266ANDA
DapsoneDapsonegel, topical0378-4830ANDA
Denavirpenciclovircream, topical0378-9720NDA
Dexlansoprazoledexlansoprazolecapsule, delayed release pellets, oral0378-2085ANDA
Dexlansoprazoledexlansoprazolecapsule, delayed release pellets, oral0378-2086ANDA
Diazepamdiazepamtablet, oral0378-0271ANDA
Diazepamdiazepamtablet, oral0378-0345ANDA
Diazepamdiazepamtablet, oral0378-0477ANDA
Diclofenac sodium and MisoprostolDiclofenac sodium and Misoprostoltablet, film coated, oral59762-0028NDA AUTHORIZED GENERIC
Diclofenac sodium and MisoprostolDiclofenac sodium and Misoprostoltablet, film coated, oral59762-0029NDA AUTHORIZED GENERIC
DifluprednateDifluprednateemulsion, ophthalmic0378-7518ANDA
Diltiazem Hydrochloridediltiazem hydrochloridecapsule, extended release, oral0378-6060ANDA
Diltiazem Hydrochloridediltiazem hydrochloridecapsule, extended release, oral0378-6090ANDA
Diltiazem Hydrochloridediltiazem hydrochloridecapsule, extended release, oral0378-6120ANDA
Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfatetablet, oral59762-1061NDA AUTHORIZED GENERIC
Disopyramide Phosphatedisopyramide phosphatecapsule, gelatin coated, oral59762-0386NDA AUTHORIZED GENERIC
Disopyramide Phosphatedisopyramide phosphatecapsule, gelatin coated, oral59762-0400NDA AUTHORIZED GENERIC
Divalproex Sodiumdivalproex sodiumtablet, film coated, extended release, oral0378-0472ANDA
Divalproex Sodiumdivalproex sodiumtablet, film coated, extended release, oral0378-0473ANDA
Doxazosindoxazosintablet, oral59762-2420NDA AUTHORIZED GENERIC
Doxazosindoxazosintablet, oral59762-2440NDA AUTHORIZED GENERIC
Doxazosindoxazosintablet, oral59762-2480NDA AUTHORIZED GENERIC
Doxazosin mesylatedoxazosin mesylatetablet, oral59762-1388NDA AUTHORIZED GENERIC
Doxazosin mesylatedoxazosin mesylatetablet, oral59762-1389NDA AUTHORIZED GENERIC
Doxazosin mesylatedoxazosin mesylatetablet, oral59762-1390NDA AUTHORIZED GENERIC
Doxazosin mesylatedoxazosin mesylatetablet, oral59762-1391NDA AUTHORIZED GENERIC
Doxepin Hydrochloridedoxepin hydrochloridecapsule, oral0378-1049ANDA
Doxepin Hydrochloridedoxepin hydrochloridecapsule, oral0378-3125ANDA
Doxepin Hydrochloridedoxepin hydrochloridecapsule, oral0378-4250ANDA
Doxepin Hydrochloridedoxepin hydrochloridecapsule, oral0378-5375ANDA
Doxepin Hydrochloridedoxepin hydrochloridecapsule, oral0378-6410ANDA
Doxepin HydrochlorideDoxepin Hydrochloridecream, topical0378-8117NDA AUTHORIZED GENERIC
-EPINEPHRINEpowder65015-846BULK INGREDIENT
-EPINEPHRINE BITARTRATEpowder65015-855BULK INGREDIENT
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLethynodiol diacetate and ethinyl estradiolkit0378-7306ANDA
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLethynodiol diacetate and ethinyl estradiolkit0378-7307ANDA
EXEMESTANEExemestanetablet, sugar coated, oral59762-2858NDA AUTHORIZED GENERIC
Eletriptan Hydrobromideeletriptan hydrobromidetablet, film coated, oral0378-4287ANDA
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Enquiry

Common questions

Is Mylan Pharmaceuticals, Inc. FDA approved?
Mylan Pharmaceuticals, Inc. holds no registered establishment of its own; 489 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Mylan Pharmaceuticals, Inc. make?
489 products are listed under Mylan Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule. 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.