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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206665

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ALISKIREN HEMIFUMARATE (ALISKIREN HEMIFUMARATE)
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: ALISKIREN HEMIFUMARATE
Proprietary Name: ALISKIREN HEMIFUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206665
Product Number: 001
Approval Date: Mar 22, 2019
Applicant Holder Full Name: ANCHEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ALISKIREN HEMIFUMARATE (ALISKIREN HEMIFUMARATE)
EQ 300MG BASE
Marketing Status: Prescription
Active Ingredient: ALISKIREN HEMIFUMARATE
Proprietary Name: ALISKIREN HEMIFUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206665
Product Number: 002
Approval Date: Mar 22, 2019
Applicant Holder Full Name: ANCHEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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