Details for New Drug Application (NDA): 200296
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, Orbion Pharms, and Pharmobedient, and is included in fourteen NDAs. It is available from seven suppliers. Additional details are available on the RISEDRONATE SODIUM profile page.
The generic ingredient in RISEDRONATE SODIUM is risedronate sodium. There is one drug master file entry for this compound. Nine 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 is one drug master file entry for this compound. Nine 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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