Details for New Drug Application (NDA): 204206
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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 204206
Tradename: | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
Applicant: | Dr Reddys |
Ingredient: | esomeprazole magnesium; naproxen |
Patents: | 0 |
Pharmacology for NDA: 204206
Mechanism of Action | Cyclooxygenase Inhibitors Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 204206
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 | 204206 | ANDA | Dr. Reddy's Laboratories Limited | 55111-289 | 55111-289-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60) |
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 204206 | ANDA | Dr. Reddy's Laboratories Limited | 55111-701 | 55111-701-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-701-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE;375MG | ||||
Approval Date: | Feb 18, 2020 | 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: | Feb 18, 2020 | TE: | AB | RLD: | No |
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