Details for New Drug Application (NDA): 018965
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The generic ingredient in NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the naproxen profile page.
Summary for 018965
| Tradename: | NAPROSYN |
| Applicant: | Atnahs Pharma Us |
| Ingredient: | naproxen |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018965
Suppliers and Packaging for NDA: 018965
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAPROSYN | naproxen | SUSPENSION;ORAL | 018965 | NDA AUTHORIZED GENERIC | Acella Pharmaceuticals, LLC | 42192-619 | 42192-619-16 | 473 mL in 1 BOTTLE (42192-619-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/ML | ||||
| Approval Date: | Mar 23, 1987 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 018965
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Atnahs Pharma Us | NAPROSYN | naproxen | SUSPENSION;ORAL | 018965-001 | Mar 23, 1987 | 3,904,682 | ⤷ Get Started Free |
| Atnahs Pharma Us | NAPROSYN | naproxen | SUSPENSION;ORAL | 018965-001 | Mar 23, 1987 | 4,009,197 | ⤷ Get Started Free |
| Atnahs Pharma Us | NAPROSYN | naproxen | SUSPENSION;ORAL | 018965-001 | Mar 23, 1987 | 4,001,301 | ⤷ Get Started Free |
| Atnahs Pharma Us | NAPROSYN | naproxen | SUSPENSION;ORAL | 018965-001 | Mar 23, 1987 | 3,998,966 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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