Details for New Drug Application (NDA): 214463
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NDA 214463 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 214463
| Tradename: | NAPROXEN SODIUM |
| Applicant: | Patheon Softgels |
| Ingredient: | naproxen sodium |
| Patents: | 0 |
Pharmacology for NDA: 214463
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 214463
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAPROXEN SODIUM | naproxen sodium | CAPSULE;ORAL | 214463 | ANDA | Bayer Healthcare LLC | 0280-0105 | 0280-0105-01 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-01) |
| NAPROXEN SODIUM | naproxen sodium | CAPSULE;ORAL | 214463 | ANDA | Bayer Healthcare LLC | 0280-0105 | 0280-0105-02 | 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jan 10, 2023 | TE: | RLD: | No | |||||
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