Details for New Drug Application (NDA): 021575
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NDA 021575 describes FOSAMAX, which is a drug marketed by Merck, Organon, and Organon Llc, and is included in three NDAs. It is available from one supplier. Additional details are available on the FOSAMAX profile page.
The generic ingredient in FOSAMAX is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.
The generic ingredient in FOSAMAX is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.
Summary for 021575
| Tradename: | FOSAMAX |
| Applicant: | Merck |
| Ingredient: | alendronate sodium |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021575
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 70MG BASE/75ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 17, 2003 | TE: | RLD: | Yes | |||||
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