Details for New Drug Application (NDA): 075416
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NDA 075416 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, 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, Hetero Labs Ltd V, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Norvium Bioscience, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Yichang Humanwell, Amneal Pharms Co, Corepharma, Granules, P And L, Perrigo R And D, and Aurobindo Pharma, and is included in forty-eight NDAs. It is available from one hundred and twenty-three suppliers. There are five 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 075416
| Tradename: | NAPROXEN SODIUM |
| Applicant: | Actavis Labs Fl Inc |
| Ingredient: | naproxen sodium |
| Patents: | 0 |
Pharmacology for NDA: 075416
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 075416
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAPROXEN SODIUM | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 075416 | ANDA | Teva Pharmaceuticals, Inc. | 0480-0951 | 0480-0951-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0951-01) |
| NAPROXEN SODIUM | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 075416 | ANDA | Teva Pharmaceuticals, Inc. | 0480-0952 | 0480-0952-58 | 75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0952-58) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Aug 27, 2002 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 375MG BASE | ||||
| Approval Date: | Apr 23, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 750MG BASE | ||||
| Approval Date: | Aug 11, 2016 | TE: | AB | RLD: | No | ||||
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