Details for New Drug Application (NDA): 075168
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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. Nine suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 075168
Tradename: | NAPROXEN SODIUM |
Applicant: | Dr Reddys Labs Inc |
Ingredient: | naproxen sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075168
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 075168
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 075168 | ANDA | Kroger Company | 30142-954 | 30142-954-10 | 1 BOTTLE in 1 CARTON (30142-954-10) / 100 TABLET, COATED in 1 BOTTLE |
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 075168 | ANDA | Kroger Company | 30142-954 | 30142-954-20 | 1 BOTTLE in 1 CARTON (30142-954-20) / 200 TABLET, COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 220MG | ||||
Approval Date: | Jul 28, 1998 | TE: | RLD: | No |
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