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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075424

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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: A075424
Product Number: 002
Approval Date: Dec 18, 2002
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES 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: Yes
TE Code: AB
Application Number: A075424
Product Number: 001
Approval Date: Mar 30, 2001
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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