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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202516

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TELMISARTAN AND AMLODIPINE (AMLODIPINE BESYLATE; TELMISARTAN)
EQ 5MG BASE;40MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; TELMISARTAN
Proprietary Name: TELMISARTAN AND AMLODIPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202516
Product Number: 001
Approval Date: Aug 26, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TELMISARTAN AND AMLODIPINE (AMLODIPINE BESYLATE; TELMISARTAN)
EQ 5MG BASE;80MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; TELMISARTAN
Proprietary Name: TELMISARTAN AND AMLODIPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202516
Product Number: 003
Approval Date: Aug 26, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TELMISARTAN AND AMLODIPINE (AMLODIPINE BESYLATE; TELMISARTAN)
EQ 10MG BASE;40MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; TELMISARTAN
Proprietary Name: TELMISARTAN AND AMLODIPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202516
Product Number: 002
Approval Date: Aug 26, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TELMISARTAN AND AMLODIPINE (AMLODIPINE BESYLATE; TELMISARTAN)
EQ 10MG BASE;80MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; TELMISARTAN
Proprietary Name: TELMISARTAN AND AMLODIPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;80MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A202516
Product Number: 004
Approval Date: Aug 26, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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