Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query on "020835."


Active Ingredient: RISEDRONATE SODIUM
Dosage Form;Route: TABLET; ORAL
Proprietary Name: ACTONEL
Applicant: WARNER CHILCOTT LLC
Strength: 30MG
Application Number: N020835
Product Number: 001
Approval Date: Mar 27, 1998
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: RISEDRONATE SODIUM
Dosage Form;Route: TABLET; ORAL
Proprietary Name: ACTONEL
Applicant: WARNER CHILCOTT LLC
Strength: 5MG
Application Number: N020835
Product Number: 002
Approval Date: Apr 14, 2000
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: RISEDRONATE SODIUM
Dosage Form;Route: TABLET; ORAL
Proprietary Name: ACTONEL
Applicant: WARNER CHILCOTT LLC
Strength: 35MG
Application Number: N020835
Product Number: 003
Approval Date: May 25, 2002
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: RISEDRONATE SODIUM
Dosage Form;Route: TABLET; ORAL
Proprietary Name: ACTONEL
Applicant: WARNER CHILCOTT LLC
Strength: 150MG
Application Number: N020835
Product Number: 005
Approval Date: Apr 22, 2008
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:
    Orange Book Data - Monthly
    Generic Drug Product Information & Patent Information - Daily
    Orange Book Data Updated Through April, 2013
    Patent and Generic Drug Product Data Last Updated: May 21, 2013
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