Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021823

ACTONEL WITH CALCIUM (COPACKAGED) (CALCIUM CARBONATE; RISEDRONATE SODIUM)
EQ 500MG BASE,N/A;N/A,35MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: CALCIUM CARBONATE; RISEDRONATE SODIUM
Proprietary Name: ACTONEL WITH CALCIUM (COPACKAGED)
Dosage Form; Route of Administration: TABLET, TABLET; ORAL
Strength: EQ 500MG BASE,N/A;N/A,35MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021823
Product Number: 001
Approval Date: Aug 12, 2005
Applicant Holder Full Name: WARNER CHILCOTT CO LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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