Details for New Drug Application (NDA): 078486
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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. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 078486
Tradename: | NAPROXEN SODIUM |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | naproxen sodium |
Patents: | 0 |
Pharmacology for NDA: 078486
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 078486
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 078486 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-494 | 43598-494-01 | 100 TABLET, FILM COATED in 1 BOTTLE (43598-494-01) |
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 078486 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-494 | 43598-494-05 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-494-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Jul 26, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Jul 26, 2007 | TE: | AB | RLD: | No |
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