Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075135

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PACERONE (AMIODARONE HYDROCHLORIDE)
100MG
Marketing Status: Prescription
Active Ingredient: AMIODARONE HYDROCHLORIDE
Proprietary Name: PACERONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075135
Product Number: 002
Approval Date: Apr 12, 2005
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PACERONE (AMIODARONE HYDROCHLORIDE)
200MG
Marketing Status: Prescription
Active Ingredient: AMIODARONE HYDROCHLORIDE
Proprietary Name: PACERONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075135
Product Number: 001
Approval Date: Apr 30, 1998
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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