Details for New Drug Application (NDA): 213699
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NDA 213699 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 three 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.
Summary for 213699
| Tradename: | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | esomeprazole magnesium; naproxen |
| Patents: | 0 |
Pharmacology for NDA: 213699
| Mechanism of Action | Cyclooxygenase Inhibitors Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 213699
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 213699 | ANDA | Ajanta Pharma USA Inc. | 27241-202 | 27241-202-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (27241-202-60) |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 213699 | ANDA | Ajanta Pharma USA Inc. | 27241-203 | 27241-203-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (27241-203-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE;375MG | ||||
| Approval Date: | Oct 6, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE;500MG | ||||
| Approval Date: | Oct 6, 2022 | TE: | AB | RLD: | No | ||||
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