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:	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

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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	⤷ Sign Up	⤷ Sign Up
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	⤷ Sign Up	⤷ Sign Up
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007	⤷ Sign Up	⤷ Sign Up
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007	⤷ Sign Up	⤷ Sign Up
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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