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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075237

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SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)
80MG
Marketing Status: Discontinued
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: 
Application Number: A075237
Product Number: 001
Approval Date: May 1, 2000
Applicant Holder Full Name: NATCO PHARMA USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)
120MG
Marketing Status: Discontinued
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: 
Application Number: A075237
Product Number: 002
Approval Date: May 1, 2000
Applicant Holder Full Name: NATCO PHARMA USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)
160MG
Marketing Status: Discontinued
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: 
Application Number: A075237
Product Number: 003
Approval Date: May 1, 2000
Applicant Holder Full Name: NATCO PHARMA USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)
240MG
Marketing Status: Discontinued
Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: SOTALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 240MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A075237
Product Number: 004
Approval Date: May 1, 2000
Applicant Holder Full Name: NATCO PHARMA USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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