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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021762


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NDA 021762 describes FOSAMAX PLUS D, which is a drug marketed by Organon Llc and is included in one NDA. It is available from one supplier. Additional details are available on the FOSAMAX PLUS D profile page.

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
Pharmacology for NDA: 021762
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:RXDosage:TABLET;ORALStrengthEQ 70MG BASE;2,800 IU
Approval Date:Apr 7, 2005TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 70MG BASE;5,600 IU
Approval Date:Apr 26, 2007TE: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 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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