Details for New Drug Application (NDA): 209735
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NDA 209735 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 209735
| Tradename: | ESOMEPRAZOLE MAGNESIUM |
| Applicant: | Sun Pharm |
| Ingredient: | esomeprazole magnesium |
| Patents: | 0 |
Pharmacology for NDA: 209735
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 209735
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 209735 | ANDA | Golden State Medical Supply, Inc. | 51407-742 | 51407-742-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-742-10) |
| ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 209735 | ANDA | Golden State Medical Supply, Inc. | 51407-742 | 51407-742-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-742-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Apr 30, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Apr 30, 2018 | TE: | AB | RLD: | No | ||||
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