Details for New Drug Application (NDA): 090545
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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 090545
Tradename: | NAPROXEN SODIUM |
Applicant: | Marksans Pharma |
Ingredient: | naproxen sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090545
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 090545
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 090545 | ANDA | WALGREENS | 0363-6099 | 0363-6099-01 | 100 TABLET, COATED in 1 BOTTLE (0363-6099-01) |
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 090545 | ANDA | WALGREENS | 0363-6099 | 0363-6099-05 | 50 TABLET, COATED in 1 BOTTLE (0363-6099-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 220MG | ||||
Approval Date: | Mar 16, 2011 | TE: | RLD: | No |
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