FDA Approval Activities for this Drug…

Primsol Solution (Trimethoprim Hydrochloride Solution), 50 mg (base)/5 mL, Only Ascent Pediatrics, NDA 74-973 Proloprim (trimethoprim) Tablets, Monarch NDA 17-943/S-016 Sulfamethoxazole and Trimethoprim Tablets, USP and Phenazopyridine Hydrochloride Tablets, USP Able NDA 21-105 6/26/01 11/6/01 11/6/01 11/7/01 Sulfamethoxazole Indication: Treatment of urinary tract infections and for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection. Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution, 1 mg (base) & 10,000 units per mL Taylor ANDA 65-006 Zotrim (Sulfamethoxazole and Trimethoprim Tablets, USP and Phenazopyridine Hydrochloride) Tablets, USP Able NDA 21-105 6/26/01 11/6/01 11/6/01 11/7/01 Zotrim Indication: Treatment of urinary tract infections and for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection. | Sulfamethoxazole and Trimethoprim Tablets, Interpharm, Approval

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