Details for New Drug Application (NDA): 076518
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The generic ingredient in NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE 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 076518
Tradename: | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE |
Applicant: | Perrigo |
Ingredient: | naproxen sodium; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 076518
Mechanism of Action | Adrenergic alpha-Agonists Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 076518
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 076518 | ANDA | Bayer HealthCare LLC. | 0280-6045 | 0280-6045-10 | 1 BLISTER PACK in 1 CARTON (0280-6045-10) / 10 TABLET in 1 BLISTER PACK |
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 076518 | ANDA | Bayer HealthCare LLC. | 0280-6090 | 0280-6090-10 | 1 BLISTER PACK in 1 CARTON (0280-6090-10) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 220MG;120MG | ||||
Approval Date: | Mar 17, 2004 | TE: | RLD: | No |
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