Details for New Drug Application (NDA): 203925
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NDA 203925 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 203925
| Tradename: | RISEDRONATE SODIUM |
| Applicant: | Sun Pharm |
| Ingredient: | risedronate sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203925
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISEDRONATE SODIUM | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 203925 | ANDA | NorthStar RxLLC | 16714-870 | 16714-870-02 | 1 DOSE PACK in 1 CARTON (16714-870-02) / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (16714-870-01) |
| RISEDRONATE SODIUM | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 203925 | ANDA | Sun Pharmaceutical Industires Inc. | 63304-440 | 63304-440-09 | 1 DOSE PACK in 1 CARTON (63304-440-09) / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 35MG | ||||
| Approval Date: | Jul 9, 2019 | TE: | AB | RLD: | No | ||||
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