Details for New Drug Application (NDA): 091432
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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 091432
Tradename: | NAPROXEN |
Applicant: | Nuvo Pharms Inc |
Ingredient: | naproxen |
Patents: | 0 |
Pharmacology for NDA: 091432
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091432
Suppliers and Packaging for NDA: 091432
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 091432 | ANDA | Cameron Pharmaceuticals | 42494-453 | 42494-453-10 | 100 TABLET in 1 BOTTLE, PLASTIC (42494-453-10) |
NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 091432 | ANDA | Cameron Pharmaceuticals | 42494-454 | 42494-454-10 | 100 TABLET in 1 BOTTLE, PLASTIC (42494-454-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 375MG | ||||
Approval Date: | Sep 19, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Sep 19, 2011 | TE: | AB | RLD: | No |
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