Details for New Drug Application (NDA): 090124
✉ Email this page to a colleague
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 090124
Tradename: | ALENDRONATE SODIUM |
Applicant: | Aurobindo Pharma |
Ingredient: | alendronate sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 090124
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090124 | ANDA | NorthStar Rx LLC | 16714-631 | 16714-631-01 | 30 TABLET in 1 BOTTLE (16714-631-01) |
ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090124 | ANDA | NorthStar Rx LLC | 16714-631 | 16714-631-02 | 100 TABLET in 1 BOTTLE (16714-631-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Aug 4, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 35MG BASE | ||||
Approval Date: | Aug 4, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 70MG BASE | ||||
Approval Date: | Aug 4, 2008 | TE: | AB | RLD: | No |
Complete Access Available with Subscription