Details for New Drug Application (NDA): 078314
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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. Eight suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 078314
Tradename: | NAPROXEN SODIUM |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | naproxen sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078314
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 078314
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 078314 | ANDA | Medsource Pharmaceuticals | 45865-519 | 45865-519-30 | 30 TABLET in 1 BOTTLE (45865-519-30) |
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 078314 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-178 | 68462-178-01 | 100 TABLET in 1 BOTTLE (68462-178-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Apr 27, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Apr 27, 2007 | TE: | AB | RLD: | No |
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