Product Details for NDA 019865
BETAPACE (SOTALOL HYDROCHLORIDE)
80MG
Marketing Status: Prescription
120MG
Marketing Status: Prescription
160MG
Marketing Status: Prescription
240MG
Marketing Status: Prescription
320MG
Marketing Status: Discontinued
80MG
Marketing Status: Prescription
Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019865
Product Number: 001
Approval Date: Oct 30, 1992
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
BETAPACE (SOTALOL HYDROCHLORIDE)
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019865
Product Number: 001
Approval Date: Oct 30, 1992
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
120MG
Marketing Status: Prescription
Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019865
Product Number: 005
Approval Date: Apr 20, 1994
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
BETAPACE (SOTALOL HYDROCHLORIDE)
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019865
Product Number: 005
Approval Date: Apr 20, 1994
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
160MG
Marketing Status: Prescription
Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 160MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019865
Product Number: 002
Approval Date: Oct 30, 1992
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
BETAPACE (SOTALOL HYDROCHLORIDE)
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 160MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019865
Product Number: 002
Approval Date: Oct 30, 1992
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
240MG
Marketing Status: Prescription
Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019865
Product Number: 003
Approval Date: Oct 30, 1992
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
BETAPACE (SOTALOL HYDROCHLORIDE)
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019865
Product Number: 003
Approval Date: Oct 30, 1992
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Prescription
Patent and Exclusivity Information
320MG
Marketing Status: Discontinued
Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 320MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019865
Product Number: 004
Approval Date: Oct 30, 1992
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: BETAPACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 320MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019865
Product Number: 004
Approval Date: Oct 30, 1992
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information