Details for New Drug Application (NDA): 207612
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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 207612
Tradename: | NAPROXEN SODIUM |
Applicant: | Novelgenix Theraps |
Ingredient: | naproxen sodium |
Patents: | 0 |
Pharmacology for NDA: 207612
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 207612
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 207612 | ANDA | Spirit Pharmaceuticals LLC | 68210-4137 | 68210-4137-1 | 1 BOTTLE in 1 CARTON (68210-4137-1) / 10 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 220MG | ||||
Approval Date: | Nov 16, 2018 | TE: | RLD: | No |
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