Details for New Drug Application (NDA): 075227
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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. Eight suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 075227
Tradename: | NAPROXEN |
Applicant: | Teva |
Ingredient: | naproxen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075227
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075227
Suppliers and Packaging for NDA: 075227
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 075227 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1005 | 0093-1005-01 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-1005-01) |
NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 075227 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1005 | 0093-1005-05 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-1005-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 375MG | ||||
Approval Date: | Jun 30, 1998 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 30, 1998 | TE: | AB | RLD: | No |
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