Details for New Drug Application (NDA): 091353
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The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 091353
Tradename: | NAPROXEN SODIUM |
Applicant: | Granules India |
Ingredient: | naproxen sodium |
Patents: | 0 |
Pharmacology for NDA: 091353
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 091353
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 091353 | ANDA | TARGET CORPORATION | 11673-764 | 11673-764-05 | 50 TABLET in 1 BOTTLE (11673-764-05) |
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 091353 | ANDA | TARGET CORPORATION | 11673-764 | 11673-764-09 | 90 TABLET in 1 BOTTLE (11673-764-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 220MG | ||||
Approval Date: | Sep 20, 2011 | TE: | RLD: | No |
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