Details for New Drug Application (NDA): 020835

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NDA 020835 describes ACTONEL, which is a drug marketed by Apil and Warner Chilcott and is included in two NDAs. It is available from two suppliers. Additional details are available on the ACTONEL profile page.

The generic ingredient in ACTONEL 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 020835

Tradename:	ACTONEL
Applicant:	Apil
Ingredient:	risedronate sodium
Patents:	0

Pharmacology for NDA: 020835

Medical Subject Heading (MeSH) Categories for 020835

Bone Density Conservation Agents
Calcium Channel Blockers

Suppliers and Packaging for NDA: 020835

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACTONEL	risedronate sodium	TABLET;ORAL	020835	NDA	Allergan, Inc.	0430-0472	0430-0472-03	4 TABLET, FILM COATED in 1 DOSE PACK (0430-0472-03)
ACTONEL	risedronate sodium	TABLET;ORAL	020835	NDA	Allergan, Inc.	0430-0472	0430-0472-07	12 TABLET, FILM COATED in 1 DOSE PACK (0430-0472-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Mar 27, 1998	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 14, 2000	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	35MG
Approval Date:	May 25, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020835

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-005	Apr 22, 2008	7,718,634*PED	⤷ Subscribe
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	6,165,513*PED	⤷ Subscribe
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	6,465,443*PED	⤷ Subscribe
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-005	Apr 22, 2008	6,165,513*PED	⤷ Subscribe
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	6,096,342*PED	⤷ Subscribe
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