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 Drug Recalls 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… 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. 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; TRIMETHOPRIM Injection 80MG/ML;16MG/ML SULFAMETHOXAZOLE AND TRIMETHOPRIM Abbott 070627 SULFAMETHOXAZOLE; TRIMETHOPRIM Injection 80MG/ML;16MG/ML SULFAMETHOXAZOLE AND TRIMETHOPRIM ELKINS SINN 070628 SULFAMETHOXAZOLE; TRIMETHOPRIM Injection 80MG/ML;16MG/ML SULFAMETHOXAZOLE AND TRIMETHOPRIM ELKINS SINN 073303 SULFAMETHOXAZOLE; TRIMETHOPRIM Injection 80MG/ML;16MG/ML SULFAMETHOXAZOLE AND TRIMETHOPRIM Gensia Sicor 018374 SULFAMETHOXAZOLE; TRIMETHOPRIM Injection 80MG/ML;16MG/ML BACTRIM WOMEN FIRST 018615 SULFAMETHOXAZOLE; TRIMETHOPRIM Suspension; 200MG/5ML;40MG/5ML SULFATRIM PEDIATRIC ALPHARMA 018615 SULFAMETHOXAZOLE; TRIMETHOPRIM Suspension; 200MG/5ML;40MG/5ML SULFATRIM ALPHARMA 074650 SULFAMETHOXAZOLE; TRIMETHOPRIM Suspension; 200MG/5ML;40MG/5ML SULFAMETHOXAZOLE AND TRIMETHOPRIM HI TECH 017598 SULFAMETHOXAZOLE; TRIMETHOPRIM Suspension; 200MG/5ML;40MG/5ML SEPTRA MONARCH 017598 SULFAMETHOXAZOLE; TRIMETHOPRIM Suspension; 200MG/5ML;40MG/5ML SEPTRA GRAPE MONARCH 018812 SULFAMETHOXAZOLE; TRIMETHOPRIM Suspension; 200MG/5ML;40MG/5ML SULFAMETHOXAZOLE AND TRIMETHOPRIM Teva 018812 SULFAMETHOXAZOLE; TRIMETHOPRIM Suspension; 200MG/5ML;40MG/5ML SULFAMETHOXAZOLE AND TRIMETHOPRIM Teva 070028 SULFAMETHOXAZOLE; TRIMETHOPRIM Suspension; 200MG/5ML;40MG/5ML SULFAMETHOXAZOLE AND TRIMETHOPRIM Teva 018598 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH Eon 070889 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 400MG;80MG SULFAMETHOXAZOLE AND TRIMETHOPRIM Geneva 070890 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM Geneva 017376 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 400MG;80MG SEPTRA MONARCH 017376 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG SEPTRA DS MONARCH 071016 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 400MG;80MG SULFAMETHOXAZOLE AND TRIMETHOPRIM Mutual 071017 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM Mutual 070022 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 400MG;80MG SULFAMETHOPRIM Par 070032 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG SULFAMETHOPRIM-DS Par 070030 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 400MG;80MG SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH PLANTEX 070215 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 400MG;80MG SULFAMETHOXAZOLE AND TRIMETHOPRIM Pliva 070216 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM Pliva 070034 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 400MG;80MG COTRIM Teva 070037 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH Teva 070048 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG COTRIM D.S. Teva 018852 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 400MG;80MG SULFAMETHOXAZOLE AND TRIMETHOPRIM Watson 018854 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH Watson 017377 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 400MG;80MG BACTRIM WOMEN FIRST 017377 SULFAMETHOXAZOLE; TRIMETHOPRIM Tablet; 800MG;160MG BACTRIM DS WOMEN FIRST | 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 | Sulfamethoxazole and Trimethoprim Oral Suspension, Teva Pharma, Approval | Sulfamethoxazole and Trimethoprim Oral Suspension USP, Vintage Pharma, Approval | Sulfamethoxazole and Trimethoprim Tablets, 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 ^ 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 © 2010 Betterchem.com