Details for New Drug Application (NDA): 022560

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NDA 022560 describes ATELVIA, which is a drug marketed by Apil and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ATELVIA profile page.

The generic ingredient in ATELVIA is risedronate sodium. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.

Summary for 022560

Tradename:	ATELVIA
Applicant:	Apil
Ingredient:	risedronate sodium
Patents:	3

Pharmacology for NDA: 022560

Medical Subject Heading (MeSH) Categories for 022560

Bone Density Conservation Agents
Calcium Channel Blockers

Suppliers and Packaging for NDA: 022560

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560	NDA	Allergan, Inc.	0430-0979	0430-0979-03	4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)
ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-0407	59762-0407-4	1 BLISTER PACK in 1 CARTON (59762-0407-4) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	35MG
Approval Date:	Oct 8, 2010	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jan 9, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
Patent:	⤷ Sign Up	Patent Expiration:	Jan 9, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
Patent:	⤷ Sign Up	Patent Expiration:	Jan 16, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022560

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	⤷ Sign Up	⤷ Sign Up
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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