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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078702

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CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
4MG
Marketing Status: Prescription
Active Ingredient: CANDESARTAN CILEXETIL
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078702
Product Number: 001
Approval Date: May 3, 2013
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
8MG
Marketing Status: Prescription
Active Ingredient: CANDESARTAN CILEXETIL
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078702
Product Number: 002
Approval Date: May 3, 2013
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
16MG
Marketing Status: Prescription
Active Ingredient: CANDESARTAN CILEXETIL
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078702
Product Number: 003
Approval Date: May 3, 2013
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
32MG
Marketing Status: Prescription
Active Ingredient: CANDESARTAN CILEXETIL
Proprietary Name: CANDESARTAN CILEXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 32MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078702
Product Number: 004
Approval Date: May 3, 2013
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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