Details for New Drug Application (NDA): 204470
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NDA 204470 describes NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Mylan, and Sciegen Pharms Inc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the NAPROXEN AND ESOMEPRAZOLE MAGNESIUM profile page.
The generic ingredient in NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.
The generic ingredient in NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.
Summary for 204470
| Tradename: | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
| Applicant: | Actavis Labs Fl Inc |
| Ingredient: | esomeprazole magnesium; naproxen |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE;375MG | ||||
| Approval Date: | Aug 24, 2022 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE;500MG | ||||
| Approval Date: | Aug 24, 2022 | TE: | RLD: | No | |||||
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