Details for New Drug Application (NDA): 079215
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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 079215
Tradename: | RISEDRONATE SODIUM |
Applicant: | Teva Pharms Usa |
Ingredient: | risedronate sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 079215
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 079215 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7771 | 0093-7771-13 | 3 BLISTER PACK in 1 CARTON (0093-7771-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-7771-19) |
RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 079215 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7771 | 0093-7771-79 | 1 BLISTER PACK in 1 CARTON (0093-7771-79) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-7771-19) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jun 13, 2014 | TE: | AB | RLD: | No |
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