Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 017377

Expand all

BACTRIM (SULFAMETHOXAZOLE; TRIMETHOPRIM)
400MG;80MG
Marketing Status: Prescription

Active Ingredient: SULFAMETHOXAZOLE; TRIMETHOPRIM
Proprietary Name: BACTRIM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG;80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017377
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BACTRIM DS (SULFAMETHOXAZOLE; TRIMETHOPRIM)
800MG;160MG
Marketing Status: Prescription

Active Ingredient: SULFAMETHOXAZOLE; TRIMETHOPRIM
Proprietary Name: BACTRIM DS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG;160MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N017377
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information