Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078578

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AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
100MG
Marketing Status: Prescription

Active Ingredient: AMIODARONE HYDROCHLORIDE
Proprietary Name: AMIODARONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078578
Product Number: 002
Approval Date: Feb 26, 2021
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
200MG
Marketing Status: Prescription

Active Ingredient: AMIODARONE HYDROCHLORIDE
Proprietary Name: AMIODARONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078578
Product Number: 001
Approval Date: Nov 6, 2008
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
400MG
Marketing Status: Prescription

Active Ingredient: AMIODARONE HYDROCHLORIDE
Proprietary Name: AMIODARONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078578
Product Number: 003
Approval Date: Feb 26, 2021
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information