Details for New Drug Application (NDA): 020560
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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: | Organon |
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 | Organon LLC | 78206-135 | 78206-135-01 | 4 TABLET in 1 BLISTER PACK (78206-135-01) |
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| Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
---|---|---|---|---|---|---|---|
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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