Details for New Drug Application (NDA): 215776
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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.
Summary for 215776
Tradename: | NAPROXEN |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | naproxen |
Patents: | 0 |
Pharmacology for NDA: 215776
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215776
Suppliers and Packaging for NDA: 215776
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN | naproxen | SUSPENSION;ORAL | 215776 | ANDA | Camber Pharmaceuticals, Inc. | 31722-682 | 31722-682-05 | 500 mL in 1 BOTTLE (31722-682-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/ML | ||||
Approval Date: | Jun 7, 2022 | TE: | AB | RLD: | No |
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