Product Details for NDA 018976
LEVATOL (PENBUTOLOL SULFATE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PENBUTOLOL SULFATE
Proprietary Name: LEVATOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018976
Product Number: 001
Approval Date: Dec 30, 1987
Applicant Holder Full Name: AUXILIUM PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
LEVATOL (PENBUTOLOL SULFATE)
Proprietary Name: LEVATOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018976
Product Number: 001
Approval Date: Dec 30, 1987
Applicant Holder Full Name: AUXILIUM PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PENBUTOLOL SULFATE
Proprietary Name: LEVATOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018976
Product Number: 004
Approval Date: Jan 5, 1989
Applicant Holder Full Name: AUXILIUM PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: LEVATOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018976
Product Number: 004
Approval Date: Jan 5, 1989
Applicant Holder Full Name: AUXILIUM PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information