Details for New Drug Application (NDA): 203533
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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 203533
Tradename: | RISEDRONATE SODIUM |
Applicant: | Macleods Pharms Ltd |
Ingredient: | risedronate sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 203533
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 203533 | ANDA | Macleods Pharmaceuticals Limited | 33342-107 | 33342-107-06 | 3 BLISTER PACK in 1 CARTON (33342-107-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 203533 | ANDA | Macleods Pharmaceuticals Limited | 33342-107 | 33342-107-07 | 30 TABLET, FILM COATED in 1 CONTAINER (33342-107-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 9, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Dec 9, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 35MG | ||||
Approval Date: | Nov 29, 2016 | TE: | AB | RLD: | No |
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