Details for New Drug Application (NDA): 212088
NDA 212088 describes ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cipla, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Speclt, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Lannett Co Inc, Macleods Pharms, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Aurobindo Pharma, Guardian Drug, Perrigo R And D, Pharmazone, Pharmobedient, Novitium Pharma, P And L, and Dexcel, and is included in fifty-one NDAs. It is available from one hundred and ten suppliers. There are two patents protecting this drug. Additional details are available on the ESOMEPRAZOLE MAGNESIUM profile page.
The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There is one drug master file entry for this compound. One hundred and twelve suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There is one drug master file entry for this compound. One hundred and twelve suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 212088
| Tradename: | ESOMEPRAZOLE MAGNESIUM |
| Applicant: | Mylan |
| Ingredient: | esomeprazole magnesium |
| Patents: | 0 |
Pharmacology for NDA: 212088
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 212088
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 212088 | ANDA | Walgreens | 0363-9977 | 0363-9977-14 | 1 BOTTLE in 1 CARTON (0363-9977-14) / 14 TABLET in 1 BOTTLE |
| ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 212088 | ANDA | Walgreens | 0363-9977 | 0363-9977-42 | 3 BOTTLE, PLASTIC in 1 CARTON (0363-9977-42) / 14 TABLET in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jun 25, 2020 | TE: | RLD: | No | |||||
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