Details for New Drug Application (NDA): 211910
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The generic ingredient in NAPROXEN 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 211910
Tradename: | NAPROXEN |
Applicant: | Novitium Pharma |
Ingredient: | naproxen |
Patents: | 0 |
Pharmacology for NDA: 211910
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 211910
Suppliers and Packaging for NDA: 211910
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN | naproxen | SUSPENSION;ORAL | 211910 | ANDA | Novitium Pharma LLC | 70954-151 | 70954-151-10 | 500 mL in 1 BOTTLE (70954-151-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/ML | ||||
Approval Date: | Mar 10, 2021 | TE: | AB | RLD: | No |
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