Details for New Drug Application (NDA): 218497
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NDA 218497 describes NAPROXEN, which is a drug marketed by Amneal, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, Novitium Pharma, Actavis Elizabeth, Aurobindo Pharma Usa, Fosun Pharma, Nuvo Pharms Inc, Pliva, Teva, Tp Anda Holdings, Adaptis, Amneal Pharms Ny, Chartwell Molecules, Dava Pharms Inc, Glenmark Pharms Ltd, Granules, Hamilton Pharms, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, L Perrigo Co, Pharmobedient, Purepac Pharm, Roxane, Sciegen Pharms, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Bionpharma, Catalent, Onesource Specialty, Patheon Softgels, Puracap Pharm Llc, Able, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Granules India, Hetero Labs Ltd V, Lnk Intl Inc, Marksans Pharma, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Sandoz, Sun Pharm Inds Ltd, Yichang Humanwell, Amneal Pharms Co, Corepharma, P And L, and Perrigo R And D, and is included in ninety NDAs. It is available from fifty-one suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAPROXEN profile page.
The generic ingredient in NAPROXEN 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 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 218497
| Tradename: | NAPROXEN |
| Applicant: | Novitium Pharma |
| Ingredient: | naproxen |
| Patents: | 0 |
Pharmacology for NDA: 218497
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 218497
Suppliers and Packaging for NDA: 218497
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 218497 | ANDA | ANI Pharmaceuticals, Inc. | 70954-925 | 70954-925-10 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-925-10) |
| NAPROXEN | naproxen | TABLET, DELAYED RELEASE;ORAL | 218497 | ANDA | ANI Pharmaceuticals, Inc. | 70954-928 | 70954-928-10 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-928-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 375MG | ||||
| Approval Date: | Jun 12, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Jun 12, 2024 | TE: | AB | RLD: | No | ||||
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