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Profile for Tradename: ACTONEL

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Summary for Tradename: ACTONEL


Pharmacology for Tradename: ACTONEL

Drug ClassBisphosphonate
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
Procter And Gamble
calcium carbonate; risedronate sodium
TABLET, TABLET; ORAL021823Aug 12, 2005RXYes6,165,513<disabled><disabled>
Procter And Gamble
risedronate sodium
TABLET; ORAL020835May 25, 2002RXYes6,096,342<disabled><disabled>
Procter And Gamble
risedronate sodium
TABLET; ORAL020835May 25, 2002RXYes5,994,329<disabled><disabled>
Procter And Gamble
risedronate sodium
TABLET; ORAL020835May 25, 2002RXYes5,583,122<disabled><disabled>
Procter And Gamble
risedronate sodium
TABLET; ORAL020835May 25, 2002RXYes6,432,932<disabled><disabled>
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Paragraph IV activity for: ACTONEL

Drugname Dosage Strength RLD Submissiondate
risedronate sodiumTablets150 mgActonel8/12/2008
risedronate sodium with calcium carbonateTablets35 mg; 500 mgActonel with Calcium12/18/2007
risedronate sodiumTablets75 mgActonel9/10/2007
risedronate sodiumTablets5 mg, 30 mg and 35 mgActonel4/23/2004
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