Details for New Drug Application (NDA): 075871
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NDA 075871 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 075871
| Tradename: | ALENDRONATE SODIUM |
| Applicant: | Chartwell Rx |
| Ingredient: | alendronate sodium |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 075871
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Apr 22, 2009 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Apr 22, 2009 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Apr 22, 2009 | TE: | RLD: | No | |||||
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