Details for New Drug Application (NDA): 090520
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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 090520
Tradename: | ALENDRONATE SODIUM |
Applicant: | Hikma |
Ingredient: | alendronate sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 090520
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALENDRONATE SODIUM | alendronate sodium | SOLUTION;ORAL | 090520 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0282 | 0054-0282-59 | 4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59) / 75 mL in 1 BOTTLE, UNIT-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 70MG BASE/75ML | ||||
Approval Date: | Feb 25, 2013 | TE: | AA | RLD: | No |
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