Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077616

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SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)
80MG
Marketing Status: Prescription

Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: SOTALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077616
Product Number: 001
Approval Date: Feb 7, 2007
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)
120MG
Marketing Status: Prescription

Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: SOTALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077616
Product Number: 002
Approval Date: Feb 7, 2007
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)
160MG
Marketing Status: Prescription

Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: SOTALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077616
Product Number: 003
Approval Date: Feb 7, 2007
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information