Details for New Drug Application (NDA): 203822
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NDA 203822 describes RISEDRONATE SODIUM, which is a drug marketed by Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Norvium Bioscience, and Orbion Pharms, and is included in fourteen NDAs. It is available from eleven suppliers. Additional details are available on the RISEDRONATE SODIUM profile page.
The generic ingredient in RISEDRONATE SODIUM is risedronate sodium. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
The generic ingredient in RISEDRONATE SODIUM is risedronate sodium. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for 203822
| Tradename: | RISEDRONATE SODIUM |
| Applicant: | Zydus Pharms |
| Ingredient: | risedronate sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203822
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISEDRONATE SODIUM | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 203822 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-075 | 68382-075-73 | 1 BLISTER PACK in 1 CARTON (68382-075-73) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
| RISEDRONATE SODIUM | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 203822 | ANDA | Zydus Lifesciences Limited | 70771-1436 | 70771-1436-4 | 1 BLISTER PACK in 1 CARTON (70771-1436-4) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 35MG | ||||
| Approval Date: | Sep 11, 2018 | TE: | RLD: | No | |||||
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