Details for New Drug Application (NDA): 078250
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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. Nine suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 078250
Tradename: | NAPROXEN |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | naproxen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078250
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078250
Suppliers and Packaging for NDA: 078250
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN | naproxen | TABLET;ORAL | 078250 | ANDA | Medsource Pharmaceuticals | 45865-610 | 45865-610-20 | 20 TABLET in 1 BOTTLE (45865-610-20) |
NAPROXEN | naproxen | TABLET;ORAL | 078250 | ANDA | A-S Medication Solutions | 50090-0481 | 50090-0481-0 | 15 TABLET in 1 BOTTLE (50090-0481-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Mar 28, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 375MG | ||||
Approval Date: | Mar 28, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Mar 28, 2007 | TE: | AB | RLD: | No |
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