Details for New Drug Application (NDA): 218497
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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 218497
Tradename: | NAPROXEN |
Applicant: | Novitium Pharma |
Ingredient: | naproxen |
Patents: | 0 |
Pharmacology for NDA: 218497
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 218497
Suppliers and Packaging for NDA: 218497
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 218497 | ANDA | ANI Pharmaceuticals, Inc. | 70954-925 | 70954-925-10 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-925-10) |
NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 218497 | ANDA | ANI Pharmaceuticals, Inc. | 70954-928 | 70954-928-10 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-928-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 375MG | ||||
Approval Date: | Jun 12, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 12, 2024 | TE: | AB | RLD: | No |
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