DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 078314
NDA 078314 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma Inc, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Mylan, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, and Watson Labs, and is included in thirty-four NDAs. It is available from one hundred and forty-five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAPROXEN SODIUM profile page.
The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 078314
| Tradename: | NAPROXEN SODIUM |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | naproxen sodium |
| Patents: | 0 |
| Therapeutic Class: | Analgesics Anti-inflammatory Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078314
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 078314
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 078314 | ANDA | Blenheim Pharmacal, Inc. | 10544-063 | E | 10544-063-20 |
| NAPROXEN SODIUM | naproxen sodium | TABLET;ORAL | 078314 | ANDA | Blenheim Pharmacal, Inc. | 10544-275 | E | 10544-275-15 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Apr 27, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Apr 27, 2007 | TE: | AB | RLD: | No | ||||
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