Details for New Drug Application (NDA): 213158
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NDA 213158 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, 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 thirteen 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 fifteen 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 fifteen suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 213158
| Tradename: | ESOMEPRAZOLE MAGNESIUM |
| Applicant: | Cisen |
| Ingredient: | esomeprazole magnesium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Sep 22, 2020 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Sep 22, 2020 | TE: | RLD: | No | |||||
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