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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020835

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ACTONEL (RISEDRONATE SODIUM)
5MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: ACTONEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020835
Product Number: 002
Approval Date: Apr 14, 2000
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ACTONEL (RISEDRONATE SODIUM)
30MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: ACTONEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020835
Product Number: 001
Approval Date: Mar 27, 1998
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ACTONEL (RISEDRONATE SODIUM)
35MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: ACTONEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 35MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020835
Product Number: 003
Approval Date: May 25, 2002
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ACTONEL (RISEDRONATE SODIUM)
150MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: ACTONEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020835
Product Number: 005
Approval Date: Apr 22, 2008
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ACTONEL (RISEDRONATE SODIUM)
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: ACTONEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020835
Product Number: 004
Approval Date: Apr 16, 2007
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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