Details for New Drug Application (NDA): 021762
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The generic ingredient in FOSAMAX PLUS D 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 021762
Tradename: | FOSAMAX PLUS D |
Applicant: | Organon Llc |
Ingredient: | alendronate sodium; cholecalciferol |
Patents: | 0 |
Suppliers and Packaging for NDA: 021762
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762 | NDA | Organon LLC | 78206-136 | 78206-136-01 | 4 TABLET in 1 BLISTER PACK (78206-136-01) |
FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762 | NDA | Organon LLC | 78206-137 | 78206-137-01 | 4 TABLET in 1 BLISTER PACK (78206-137-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 70MG BASE;2,800 IU | ||||
Approval Date: | Apr 7, 2005 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 70MG BASE;5,600 IU | ||||
Approval Date: | Apr 26, 2007 | TE: | RLD: | Yes |
Expired US Patents for NDA 021762
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-001 | Apr 7, 2005 | ⤷ Subscribe | ⤷ Subscribe |
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-002 | Apr 26, 2007 | ⤷ Subscribe | ⤷ Subscribe |
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-001 | Apr 7, 2005 | ⤷ Subscribe | ⤷ Subscribe |
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