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Details for New Drug Application (NDA): 021823

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NDA 021823 describes ACTONEL WITH CALCIUM (COPACKAGED), which is a drug marketed by Warner Chilcott and is included in one NDA. There are five patents protecting this drug. 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 fifty-nine drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for NDA: 021823

Warner Chilcott
calcium carbonate; risedronate sodium
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, TABLET;ORALStrengthEQ 500MG BASE,N/A;N/A,35MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 12, 2005TE:RLD:Yes
Patent:5,994,329*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,015,801*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,165,513*PEDPatent Expiration:Dec 10, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021823

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner Chilcott
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 20055,583,122*PED► subscribe
Warner Chilcott
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 20056,096,342*PED► subscribe
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