Details for New Drug Application (NDA): 077132
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NDA 077132 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 eight 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for 077132
| Tradename: | RISEDRONATE SODIUM |
| Applicant: | Teva Pharms Usa |
| Ingredient: | risedronate sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077132
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 077132 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3098 | 0093-3098-29 | 12 BLISTER PACK in 1 CARTON (0093-3098-29) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) |
| RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 077132 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3098 | 0093-3098-44 | 4 BLISTER PACK in 1 CARTON (0093-3098-44) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 5, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Oct 5, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 35MG | ||||
| Approval Date: | Oct 5, 2007 | TE: | AB | RLD: | No | ||||
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