Details for New Drug Application (NDA): 090258
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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 090258
Tradename: | ALENDRONATE SODIUM |
Applicant: | Hangzhou Binjiang |
Ingredient: | alendronate sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 090258
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090258 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-718 | 10135-718-12 | 3 BLISTER PACK in 1 CARTON (10135-718-12) / 4 TABLET in 1 BLISTER PACK |
ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090258 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-718 | 10135-718-44 | 1 BLISTER PACK in 1 CARTON (10135-718-44) / 4 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Sep 24, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Sep 24, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 35MG BASE | ||||
Approval Date: | Sep 24, 2009 | TE: | AB | RLD: | No |
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