Details for New Drug Application (NDA): 090877
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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 090877
Tradename: | RISEDRONATE SODIUM |
Applicant: | Apotex |
Ingredient: | risedronate sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 090877
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 090877 | ANDA | Apotex Corp. | 60505-3096 | 60505-3096-2 | 1 BLISTER PACK in 1 CARTON (60505-3096-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK |
RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 090877 | ANDA | Apotex Corp. | 60505-3097 | 60505-3097-2 | 1 BLISTER PACK in 1 CARTON (60505-3097-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 35MG | ||||
Approval Date: | Nov 30, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Jun 10, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jun 10, 2014 | TE: | AB | RLD: | No |
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