Product Details for NDA 017560
BACTRIM (SULFAMETHOXAZOLE; TRIMETHOPRIM)
200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: SULFAMETHOXAZOLE; TRIMETHOPRIM
Proprietary Name: BACTRIM
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017560
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
BACTRIM PEDIATRIC (SULFAMETHOXAZOLE; TRIMETHOPRIM)
Proprietary Name: BACTRIM
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017560
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: SULFAMETHOXAZOLE; TRIMETHOPRIM
Proprietary Name: BACTRIM PEDIATRIC
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017560
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: BACTRIM PEDIATRIC
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 200MG/5ML;40MG/5ML **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: N017560
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information