Details for New Drug Application (NDA): 021823

NDA 021823 describes ACTONEL WITH CALCIUM (COPACKAGED), which is a drug marketed by Warner Chilcott and is included in one NDA. Additional details are available on the ACTONEL WITH CALCIUM (COPACKAGED) profile page.

The generic ingredient in ACTONEL WITH CALCIUM (COPACKAGED) is calcium carbonate; risedronate sodium. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for 021823

Tradename:	ACTONEL WITH CALCIUM (COPACKAGED)
Applicant:	Warner Chilcott
Ingredient:	calcium carbonate; risedronate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE;35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Aug 12, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021823

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,165,513*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	5,583,122*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,465,443*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,432,932*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,096,342*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,015,801*PED

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