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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 000793

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BUTISOL SODIUM (BUTABARBITAL SODIUM)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BUTABARBITAL SODIUM
Proprietary Name: BUTISOL SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N000793
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
BUTISOL SODIUM (BUTABARBITAL SODIUM)
30MG
Marketing Status: Discontinued
Active Ingredient: BUTABARBITAL SODIUM
Proprietary Name: BUTISOL SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N000793
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
BUTISOL SODIUM (BUTABARBITAL SODIUM)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BUTABARBITAL SODIUM
Proprietary Name: BUTISOL SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N000793
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
BUTISOL SODIUM (BUTABARBITAL SODIUM)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BUTABARBITAL SODIUM
Proprietary Name: BUTISOL SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N000793
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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