Details for New Drug Application (NDA): 074190
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The generic ingredient in NAPROXEN 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.
Pharmacology for NDA: 074190
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074190
Suppliers and Packaging for NDA: 074190
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN | naproxen | SUSPENSION;ORAL | 074190 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3630 | 0054-3630-63 | 500 mL in 1 BOTTLE, PLASTIC (0054-3630-63) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/ML | ||||
Approval Date: | Mar 30, 1994 | TE: | AB | RLD: | No |
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