Details for New Drug Application (NDA): 214278
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NDA 214278 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 Ltd, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Aurobindo Pharma, Guardian Drug, Marksans Pharma, Perrigo R And D, Pharmobedient, P And L, and Dexcel, and is included in fifty NDAs. It is available from one hundred and eleven 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 are seventy-four drug master file entries for this compound. One hundred and thirteen 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 are seventy-four drug master file entries for this compound. One hundred and thirteen suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 214278
| Tradename: | ESOMEPRAZOLE MAGNESIUM |
| Applicant: | Dexcel |
| Ingredient: | esomeprazole magnesium |
| Patents: | 2 |
Pharmacology for NDA: 214278
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 214278
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 214278 | NDA | Dexcel Pharma Technologies Ltd | 64239-112 | 64239-112-02 | 2 BLISTER PACK in 1 CARTON (64239-112-02) / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 214278 | NDA | Dexcel Pharma Technologies Ltd | 64239-112 | 64239-112-03 | 2 CARTON in 1 CARTON (64239-112-03) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Oct 20, 2020 | TE: | RLD: | Yes | |||||
| Patent: | 10,076,494 | Patent Expiration: | Dec 8, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,835,488 | Patent Expiration: | Dec 8, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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