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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200909

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EZETIMIBE AND SIMVASTATIN (EZETIMIBE; SIMVASTATIN)
10MG;10MG
Marketing Status: Prescription
Active Ingredient: EZETIMIBE; SIMVASTATIN
Proprietary Name: EZETIMIBE AND SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200909
Product Number: 001
Approval Date: Apr 26, 2017
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Prescription
Patent and Exclusivity Information
EZETIMIBE AND SIMVASTATIN (EZETIMIBE; SIMVASTATIN)
10MG;20MG
Marketing Status: Prescription
Active Ingredient: EZETIMIBE; SIMVASTATIN
Proprietary Name: EZETIMIBE AND SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200909
Product Number: 002
Approval Date: Apr 26, 2017
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Prescription
Patent and Exclusivity Information
EZETIMIBE AND SIMVASTATIN (EZETIMIBE; SIMVASTATIN)
10MG;40MG
Marketing Status: Prescription
Active Ingredient: EZETIMIBE; SIMVASTATIN
Proprietary Name: EZETIMIBE AND SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200909
Product Number: 003
Approval Date: Apr 26, 2017
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Prescription
Patent and Exclusivity Information
EZETIMIBE AND SIMVASTATIN (EZETIMIBE; SIMVASTATIN)
10MG;80MG
Marketing Status: Prescription
Active Ingredient: EZETIMIBE; SIMVASTATIN
Proprietary Name: EZETIMIBE AND SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200909
Product Number: 004
Approval Date: Apr 26, 2017
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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