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Naproxen sodium - Generic Drug Details
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There are forty-two drug master file entries for naproxen sodium. One hundred and fifty-five suppliers are listed for this compound.
Summary for Generic Name: naproxen sodium
| Tradenames: | 8 |
| Patents: | 5 |
| Applicants: | 28 |
| NDAs: | 38 |
| Drug Master File Entries: see list | 42 |
| Suppliers / Packaging: see list | 155 |
| Therapeutic Class: | Analgesics Anti-inflammatory Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: naproxen sodium
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Clinical Trials for: naproxen sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pernix Ireland Ltd | TREXIMET | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 021926-002 | May 14, 2015 | RX | No | 6,586,458*PED | Feb 14, 2018 | Y | |||||||||||||||||||
Teva | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 074142-002 | Dec 21, 1993 | DISCN | No | ||||||||||||||||||||||
Marksans Pharma | NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 090545-001 | Mar 16, 2011 | OTC | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: naproxen sodium
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alvogen Malta | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-001 | Jan 5, 1996 | 5,637,320 | <disabled> | ||||||||||||||||||||||
Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | 4,001,301 | <disabled> | ||||||||||||||||||||||
Atnahs Pharma Us | ANAPROX DS | naproxen sodium | TABLET;ORAL | 018164-003 | Sep 30, 1987 | 3,998,966 | <disabled> | ||||||||||||||||||||||
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