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

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