Details for New Drug Application (NDA): 211360
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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 211360
Tradename: | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | naproxen sodium; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 211360
Mechanism of Action | Adrenergic alpha-Agonists Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 211360
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 | 211360 | ANDA | Aurohealth LLC | 58602-816 | 58602-816-67 | 2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211360 | ANDA | Aurohealth LLC | 58602-816 | 58602-816-83 | 1 BLISTER PACK in 1 CARTON (58602-816-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 220MG;120MG | ||||
Approval Date: | Jun 1, 2022 | TE: | RLD: | No |
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