Product Details for NDA 009182
LIPO GANTRISIN (SULFISOXAZOLE ACETYL)
EQ 1GM BASE/5ML
Marketing Status: Discontinued
EQ 500MG BASE/5ML
Marketing Status: Discontinued
EQ 500MG BASE/5ML
Marketing Status: Discontinued
EQ 1GM BASE/5ML
Marketing Status: Discontinued
Active Ingredient: SULFISOXAZOLE ACETYL
Proprietary Name: LIPO GANTRISIN
Dosage Form; Route of Administration: EMULSION; ORAL
Strength: EQ 1GM BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N009182
Product Number: 009
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
GANTRISIN PEDIATRIC (SULFISOXAZOLE ACETYL)
Proprietary Name: LIPO GANTRISIN
Dosage Form; Route of Administration: EMULSION; ORAL
Strength: EQ 1GM BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N009182
Product Number: 009
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 500MG BASE/5ML
Marketing Status: Discontinued
Active Ingredient: SULFISOXAZOLE ACETYL
Proprietary Name: GANTRISIN PEDIATRIC
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: EQ 500MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N009182
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
GANTRISIN (SULFISOXAZOLE ACETYL)
Proprietary Name: GANTRISIN PEDIATRIC
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: EQ 500MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N009182
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 500MG BASE/5ML
Marketing Status: Discontinued
Active Ingredient: SULFISOXAZOLE ACETYL
Proprietary Name: GANTRISIN
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: EQ 500MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N009182
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: GANTRISIN
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: EQ 500MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N009182
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information