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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200477

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RISEDRONATE SODIUM (RISEDRONATE SODIUM)
5MG
Marketing Status: Discontinued
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200477
Product Number: 001
Approval Date: Nov 30, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
RISEDRONATE SODIUM (RISEDRONATE SODIUM)
30MG
Marketing Status: Discontinued
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200477
Product Number: 002
Approval Date: Nov 30, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
RISEDRONATE SODIUM (RISEDRONATE SODIUM)
35MG
Marketing Status: Discontinued
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 35MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200477
Product Number: 003
Approval Date: Nov 30, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
RISEDRONATE SODIUM (RISEDRONATE SODIUM)
75MG
Marketing Status: Discontinued
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200477
Product Number: 004
Approval Date: Jun 10, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
RISEDRONATE SODIUM (RISEDRONATE SODIUM)
150MG
Marketing Status: Discontinued
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: RISEDRONATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200477
Product Number: 005
Approval Date: Jun 10, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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