Details for New Drug Application (NDA): 214512
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The generic ingredient in ALENDRONATE SODIUM is alendronate sodium. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for 214512
Tradename: | ALENDRONATE SODIUM |
Applicant: | Novitium Pharma |
Ingredient: | alendronate sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 214512
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALENDRONATE SODIUM | alendronate sodium | SOLUTION;ORAL | 214512 | ANDA | ANI Pharmaceuticals, Inc. | 70954-264 | 70954-264-10 | 4 BOTTLE in 1 CARTON (70954-264-10) / 75 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 70MG BASE/75ML | ||||
Approval Date: | May 11, 2023 | TE: | AA | RLD: | No |
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