Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017376

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

Active Ingredient: SULFAMETHOXAZOLE; TRIMETHOPRIM
Proprietary Name: SEPTRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: N017376
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MONARCH PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: SULFAMETHOXAZOLE; TRIMETHOPRIM
Proprietary Name: SEPTRA DS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG;160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: N017376
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MONARCH PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information