Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Septra (trimethoprim/sulfamethoxazole) Tablets and DS Tablets, King Pharma, Labeling Revision | Septra (trimethoprim/sulfamethoxazole) Suspension, King Pharma, Labeling Revision | Sulfamethoxazole & Trimethoprim Tablets, Vista Pharma, Approval | Proloprim (trimethoprim) tablets, King Pharma, Labeling Revision | Sulfamethoxazole and Trimethoprim Oral Suspension, Teva Pharma, Approval | Sulfamethoxazole and Trimethoprim Oral Suspension USP, Vintage Pharma, Approval | Bactrim (sulfamethoxazoole and trimethoprim) Tablets, Mutual Pharma, Labeling Revision | Septra and Septra DS (trimethoprim/sulfamethoxazole) Tablets, Monarch Pharma, Labeling Revision | Sulfamethoxazole and Trimethoprim Tablets, Interpharm, Inc., Control Suppl. | Septra (sulfamethoxazole; trimethoprim) Tablets, and Septra DS (sulfamethoxazole; trimethoprim) Tablets, Monarch Pharms, Labeling Revision | Septra (sulfamethoxazole; trimethoprim) Suspension, Monarch Pharms, Labeling Revision | Septra (sulfamethoxazole; trimethoprim) I.V., Monarch Pharms, Labeling Revision | Sulfamethoxazole and Trimethoprim Tablets USP, Aurobindo Pharma Ltd., Approval | Sulfamethoxazole and Trimethoprim Oral Suspension, Aurobindo Pharma, Ltd., Approval | Bactrim (sulfamethoxazole and trimethoprim) Tablets, Mutual Pharmaceutical Co., Inc., Labeling Revision | Bactrim (sulfamethoxazole and trimethoprim) Tablets, Mutual Pharmaceutical Co., Inc., Labeling Revision | Bactrim DS (sulfamethoxazole and trimethoprim) Tablets, Mutual Pharmaceutical Co., Inc., Labeling Revision | Trimethoprim Tablets, Novel Laboratories, Inc., Approval ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com