Details for New Drug Application (NDA): 018164
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NDA 018164 describes ANAPROX DS, 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 ANAPROX DS profile page.
The generic ingredient in ANAPROX DS is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and thirty-five suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.
The generic ingredient in ANAPROX DS is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and thirty-five suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.
Summary for 018164
| Tradename: | ANAPROX DS |
| Applicant: | Atnahs Pharma Us |
| Ingredient: | naproxen sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018164
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 018164
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANAPROX | naproxen sodium | TABLET;ORAL | 018164 | NDA | Canton Laboratories | 69437-203 | 69437-203-01 | 100 TABLET in 1 BOTTLE, PLASTIC (69437-203-01) |
| ANAPROX | naproxen sodium | TABLET;ORAL | 018164 | NDA | Woodward Pharma Services LLC | 69784-550 | 69784-550-01 | 100 TABLET in 1 BOTTLE, PLASTIC (69784-550-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Sep 30, 1987 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 018164
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
| Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
| Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
| Atnahs Pharma Us | ANAPROX | naproxen sodium | TABLET;ORAL | 018164-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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