Details for New Drug Application (NDA): 075710
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NDA 075710 describes ALENDRONATE SODIUM, which is a drug marketed by Hikma, Novitium Pharma, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Ipca Labs Ltd, Jubilant Cadista, Mylan, Rising, Sun Pharm, Teva Pharms, and Watson Labs, and is included in sixteen NDAs. It is available from nineteen suppliers. Additional details are available on the ALENDRONATE SODIUM profile page.
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.
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 075710
| Tradename: | ALENDRONATE SODIUM |
| Applicant: | Impax Labs Inc |
| Ingredient: | alendronate sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075710
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1676 | 0115-1676-01 | 100 TABLET in 1 BOTTLE (0115-1676-01) |
| ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1676 | 0115-1676-08 | 30 TABLET in 1 BOTTLE (0115-1676-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Feb 6, 2008 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Feb 6, 2008 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 35MG BASE | ||||
| Approval Date: | Feb 6, 2008 | TE: | RLD: | No | |||||
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