Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021151

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

Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE AF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021151
Product Number: 001
Approval Date: Feb 22, 2000
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE AF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021151
Product Number: 002
Approval Date: Feb 22, 2000
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE AF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 160MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021151
Product Number: 003
Approval Date: Feb 22, 2000
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BETAPACE AF (SOTALOL HYDROCHLORIDE)
40MG
Marketing Status: Discontinued

Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE AF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021151
Product Number: 006
Approval Date: Apr 2, 2003
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

BETAPACE AF (SOTALOL HYDROCHLORIDE)
60MG
Marketing Status: Discontinued

Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE AF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021151
Product Number: 007
Approval Date: Apr 2, 2003
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

BETAPACE AF (SOTALOL HYDROCHLORIDE)
100MG
Marketing Status: Discontinued

Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: BETAPACE AF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021151
Product Number: 005
Approval Date: Mar 14, 2003
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information