Details for New Drug Application (NDA): 206768
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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 206768
Tradename: | RISEDRONATE SODIUM |
Applicant: | Aurobindo Pharma |
Ingredient: | risedronate sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206768
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 206768 | ANDA | Aurobindo Pharma Limited | 65862-870 | 65862-870-03 | 1 BLISTER PACK in 1 CARTON (65862-870-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK |
RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 206768 | ANDA | Aurobindo Pharma Limited | 65862-870 | 65862-870-11 | 1 BLISTER PACK in 1 CARTON (65862-870-11) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Oct 21, 2016 | TE: | AB | RLD: | No |
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