Details for New Drug Application (NDA): 216349
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NDA 216349 describes ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Speclt, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Ivax Sub Teva Pharms, Lannett Co Inc, Macleods Pharms Ltd, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Anda Repository, Aurobindo Pharma, Marksans Pharma, Norvium Bioscience, Perrigo R And D, Cipla, P And L, and Dexcel, and is included in forty-five NDAs. It is available from one hundred and eight 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 ten 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 ten suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 216349
| Tradename: | ESOMEPRAZOLE MAGNESIUM |
| Applicant: | Graviti Pharms |
| Ingredient: | esomeprazole magnesium |
| Patents: | 0 |
Pharmacology for NDA: 216349
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 216349
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 216349 | ANDA | Rising Pharma Holdings, Inc. | 16571-880 | 16571-880-41 | 1 BOTTLE in 1 CARTON (16571-880-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 216349 | ANDA | Rising Pharma Holdings, Inc. | 16571-880 | 16571-880-42 | 3 BOTTLE in 1 CARTON (16571-880-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jun 24, 2022 | TE: | RLD: | No | |||||
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