Details for New Drug Application (NDA): 020067
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NDA 020067 describes EC-NAPROSYN, which is a drug marketed by Atnahs Pharma Us and is included in one NDA. It is available from two suppliers. Additional details are available on the EC-NAPROSYN profile page.
The generic ingredient in EC-NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the naproxen profile page.
The generic ingredient in EC-NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the naproxen profile page.
Summary for 020067
| Tradename: | EC-NAPROSYN |
| Applicant: | Atnahs Pharma Us |
| Ingredient: | naproxen |
| Patents: | 0 |
Pharmacology for NDA: 020067
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 020067
Suppliers and Packaging for NDA: 020067
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EC-NAPROSYN | naproxen | TABLET, DELAYED RELEASE;ORAL | 020067 | NDA | Bryant Ranch Prepack | 72162-1935 | 72162-1935-1 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-1935-1) |
| EC-NAPROSYN | naproxen | TABLET, DELAYED RELEASE;ORAL | 020067 | NDA AUTHORIZED GENERIC | Zameer Pharmaceuticals LLC | 90096-161 | 90096-161-01 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (90096-161-01) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 375MG | ||||
| Approval Date: | Oct 14, 1994 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Oct 14, 1994 | TE: | AB | RLD: | Yes | ||||
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