Details for New Drug Application (NDA): 202803
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NDA 202803 describes SUMATRIPTAN AND NAPROXEN SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Rising, and Sun Pharm, and is included in three NDAs. It is available from three suppliers. Additional details are available on the SUMATRIPTAN AND NAPROXEN SODIUM profile page.
The generic ingredient in SUMATRIPTAN AND NAPROXEN SODIUM is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.
The generic ingredient in SUMATRIPTAN AND NAPROXEN SODIUM is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.
Summary for 202803
| Tradename: | SUMATRIPTAN AND NAPROXEN SODIUM |
| Applicant: | Sun Pharm |
| Ingredient: | naproxen sodium; sumatriptan succinate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202803
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUMATRIPTAN AND NAPROXEN SODIUM | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 202803 | ANDA | NorthStar RxLLC | 16714-891 | 16714-891-01 | 9 TABLET, FILM COATED in 1 BOTTLE (16714-891-01) |
| SUMATRIPTAN AND NAPROXEN SODIUM | naproxen sodium; sumatriptan succinate | TABLET;ORAL | 202803 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-410 | 47335-410-22 | 9 TABLET, FILM COATED in 1 BOTTLE (47335-410-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 85MG BASE | ||||
| Approval Date: | Jul 20, 2018 | TE: | AB | RLD: | No | ||||
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