Details for New Drug Application (NDA): 017581
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NDA 017581 describes NAPROSYN, which is a drug marketed by Atnahs Pharma Us and is included in two NDAs. It is available from four suppliers. Additional details are available on the NAPROSYN profile page.
The generic ingredient in NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the naproxen profile page.
The generic ingredient in NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the naproxen profile page.
Summary for 017581
| Tradename: | NAPROSYN |
| Applicant: | Atnahs Pharma Us |
| Ingredient: | naproxen |
| Patents: | 0 |
Pharmacology for NDA: 017581
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 017581
Suppliers and Packaging for NDA: 017581
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAPROSYN | naproxen | TABLET;ORAL | 017581 | NDA | Canton Laboratories | 69437-316 | 69437-316-01 | 100 TABLET in 1 BOTTLE, PLASTIC (69437-316-01) |
| NAPROSYN | naproxen | TABLET;ORAL | 017581 | NDA | Woodward Pharma Services LLC | 69784-505 | 69784-505-01 | 100 TABLET in 1 BOTTLE, PLASTIC (69784-505-01) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 375MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 15, 1982 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 017581
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-003 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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