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Details for New Drug Application (NDA): 020560
NDA 020560 describes FOSAMAX, which is a drug marketed by Merck and Merck And Co Inc and is included in three NDAs. It is available from one supplier. There are three patents protecting this drug and two Paragraph IV challenges. 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 020560
| Tradename: | FOSAMAX |
| Applicant: | Merck And Co Inc |
| Ingredient: | alendronate sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020560
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSAMAX | alendronate sodium | TABLET;ORAL | 020560 | NDA | Merck Sharp & Dohme Corp. | 0006-0031 | 0006-0031-44 | 4 TABLET in 1 BLISTER PACK (0006-0031-44) |
Paragraph IV (Patent) Challenges for 020560
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FOSAMAX | TABLET;ORAL | alendronate sodium | 020560 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Sep 29, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Sep 29, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Apr 25, 1997 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020560
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | Start Trial | Start Trial |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | Start Trial | Start Trial |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | Start Trial | Start Trial |
| Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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