Details for New Drug Application (NDA): 200629
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The generic ingredient in NAPROXEN SODIUM 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 200629
Tradename: | NAPROXEN SODIUM |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | naproxen sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 200629
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 200629
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 200629 | ANDA | A-S Medication Solutions | 50090-3352 | 50090-3352-3 | 20 TABLET, FILM COATED in 1 BOTTLE (50090-3352-3) |
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 200629 | ANDA | A-S Medication Solutions | 50090-3352 | 50090-3352-5 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-3352-5) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Oct 31, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Oct 31, 2011 | TE: | AB | RLD: | No |
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