Product Details for NDA 018917
SECTRAL (ACEBUTOLOL HYDROCHLORIDE)
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACEBUTOLOL HYDROCHLORIDE
Proprietary Name: SECTRAL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018917
Product Number: 001
Approval Date: Dec 28, 1984
Applicant Holder Full Name: PROMIUS PHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
SECTRAL (ACEBUTOLOL HYDROCHLORIDE)
Proprietary Name: SECTRAL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018917
Product Number: 001
Approval Date: Dec 28, 1984
Applicant Holder Full Name: PROMIUS PHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACEBUTOLOL HYDROCHLORIDE
Proprietary Name: SECTRAL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018917
Product Number: 003
Approval Date: Dec 28, 1984
Applicant Holder Full Name: PROMIUS PHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SECTRAL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018917
Product Number: 003
Approval Date: Dec 28, 1984
Applicant Holder Full Name: PROMIUS PHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information