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… Nebcin (tobramycin sulfate injection, USP)-Vials and Hyporets, Eli Lilly and Company NDA 50-477/S-024 & 50-519/S-024 TOBI (tobramycin solution for inhalation), Chiron NDA 50-753/S02 3/21/02 3/29/02 Tobradex (tobramycin and dexamethasone) Ophthalmic Suspension, Alcon, NDA 50-592/S32 6/23/03 7/6/03 Tobradex (tobramycin and dexamethasone ophthalmic ointment), Alcon, NDA 50-616/S-016, S-017 & S-019 3/18/03 3/26/03 3/26/03 Tobramycin Injection, 10 & 40 mg/mL, American Pharmaceutical Partners, ANDA 65-122 11/29/02 Tobramycin Injection, 40 mg/mL, American Pharmaceutical Partners, ANDA 65-120 11/29/02 Tobramycin Solution for Inhalation, 300 mg/5 mL vials, Roxane, ANDA 65-105 12/31/02 Tobramycin Injection, 1.2 g/vial, Pharma-Tek ANDA 65-013 8/17/01 Tobramycin Ophthalmic Solution USP, 0.3%, Novex Pharma ANDA 65-087 2/25/02 10/10/02 Tobramycin Ophthalmic Solution USP, 0.3%, Altana ANDA 65-026 9/11/01 4/10/03 Tobramycin and Dexamethasone ophthalmic suspension USP, 0.3%,/0.1%, Bausch & Lomb ANDA 64-134 10/27/99 12/30/99 1/17/02 Tobradex (tobramycin and dexamethasone) ophthalmic suspension, Alcon, NDA 50-592/S-032 6/23/03 7/8/03 Tobraflex (tobraymycin) Ophthalmic Drops Alcon ANDA 50-628 5/7/01 4/23/03 Tobrex (tobramycin) Ophthalmic Ointment, 0.3%, Alcon, NDA 50-555/S-017, S-018 & S-019 3/18/03 3/26/03 3/26/03 Tobrex (tobramycin) Ophthalmic Solution, 0.3%, Falcon NDA 50 -541/S17 DEXAMETHASONE; TOBRAMYCIN Ointment; Ophthalmic 0.1%;0.3% TOBRADEX Alcon 050592 DEXAMETHASONE; TOBRAMYCIN Suspension/Drops; Ophthalmic 0.1%;0.3% TOBRADEX Alcon 064134 DEXAMETHASONE; TOBRAMYCIN Suspension/Drops; Ophthalmic 0.1%;0.3% TOBRAMYCIN AND DEXAMETHASONE BAUSCH AND LOMB 050628 FLUOROMETHOLONE ACETATE; TOBRAMYCIN Suspension/Drops; Ophthalmic 0.1%;0.3% TOBRASONE Alcon 050555 TOBRAMYCIN Ointment; Ophthalmic 0.3% TOBREX Alcon 064096 AT TOBRAMYCIN Solution/Drops; Ophthalmic 0.3% AKTOB Akorn 062535 AT TOBRAMYCIN Solution/Drops; Ophthalmic 0.3% TOBREX Alcon 065026 AT TOBRAMYCIN Solution/Drops; Ophthalmic 0.3% TOBRAMYCIN Altana 064052 AT TOBRAMYCIN Solution/Drops; Ophthalmic 0.3% TOBRAMYCIN BAUSCH AND LOMB 050541 AT TOBRAMYCIN Solution/Drops; Ophthalmic 0.3% TOBREX FALCON 065087 AT TOBRAMYCIN Solution/Drops; Ophthalmic 0.3% TOBRAMYCIN Novex 050753 TOBRAMYCIN Solution; Inhalation 300MG/5ML TOBI CHIRON 063081 TOBRAMYCIN SULFATE Injection 1.2MG BASE/ML TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 063081 TOBRAMYCIN SULFATE Injection 1.6MG BASE/ML TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 063112 TOBRAMYCIN SULFATE Injection 10MG BASE/ML TOBRAMYCIN SULFATE Abbott 063080 TOBRAMYCIN SULFATE Injection 10MG BASE/ML TOBRAMYCIN SULFATE Abbott 063116 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN SULFATE Abbott 063111 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN SULFATE Abbott 063161 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN SULFATE Abbott 063081 TOBRAMYCIN SULFATE Injection 80MG BASE/100ML TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 065122 TOBRAMYCIN SULFATE Injection 10MG BASE/ML TOBRAMYCIN AM PARTNERS 065122 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN AM PARTNERS 065120 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN (PHARMACY BULK) AM PARTNERS 064021 TOBRAMYCIN SULFATE Injection 10MG BASE/ML TOBRAMYCIN SULFATE APOTHECON 064021 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN SULFATE APOTHECON 063118 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN SULFATE Baxter 063117 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN SULFATE Baxter 063100 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN SULFATE Gensia Sicor 050519 TOBRAMYCIN SULFATE Injection 1.2GM BASE/VIAL NEBCIN LILLY 050477 TOBRAMYCIN SULFATE Injection 10MG BASE/ML NEBCIN LILLY 062707 TOBRAMYCIN SULFATE Injection 10MG BASE/ML NEBCIN LILLY 062008 TOBRAMYCIN SULFATE Injection 10MG BASE/ML NEBCIN LILLY 062008 TOBRAMYCIN SULFATE Injection 40MG BASE/ML NEBCIN LILLY 062945 TOBRAMYCIN SULFATE Injection 10MG BASE/ML TOBRAMYCIN SULFATE MARSAM 062945 TOBRAMYCIN SULFATE Injection 40MG BASE/ML TOBRAMYCIN SULFATE MARSAM 065013 TOBRAMYCIN SULFATE Injection 1.2GM BASE/VIAL TOBRAMYCIN TEK Tobradex (tobramycin and dexamethasone ophthalmic ointment), Alcon Laboratories, Labeling Revision Tobrex (tobramycin ophthalmic ointment), Alcon Laboratories, Labeling Revision | Zylet (loteprednol etabonate and tobramycin) ophthalmic suspension, Bausch & Lomb, Approval | Tobramycin (tobramycin sulfate) Injection, Akorn-Strides, Approval | Tobi (tobramycin) Inhalation Solution, Novartis Pharmaceuticals Corp., Labeling Revision ^ 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com