Details for New Drug Application (NDA): 200296
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NDA 200296 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 200296
| Tradename: | RISEDRONATE SODIUM |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | risedronate sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200296
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 200296 | ANDA | Aurobindo Pharma Limited | 65862-517 | 65862-517-22 | 2000 TABLET, FILM COATED in 1 BOTTLE (65862-517-22) |
| RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 200296 | ANDA | Aurobindo Pharma Limited | 65862-517 | 65862-517-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-517-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 30, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Nov 30, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 35MG | ||||
| Approval Date: | Nov 30, 2015 | TE: | AB | RLD: | No | ||||
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