Product Details for NDA 017534
FIORINAL (ASPIRIN; BUTALBITAL; CAFFEINE)
325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; BUTALBITAL; CAFFEINE
Proprietary Name: FIORINAL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017534
Product Number: 005
Approval Date: Apr 16, 1986
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
FIORINAL (ASPIRIN; BUTALBITAL; CAFFEINE)
Proprietary Name: FIORINAL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017534
Product Number: 005
Approval Date: Apr 16, 1986
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; BUTALBITAL; CAFFEINE
Proprietary Name: FIORINAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017534
Product Number: 003
Approval Date: Apr 16, 1986
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: FIORINAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017534
Product Number: 003
Approval Date: Apr 16, 1986
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information