FDA Approval Activities for this Drug…

Dexamethasone Sodium Phosphate Injection, 10 mg, American Pharmaceutical ANDA 40-491 Maxidex (dexamethasone ophthalmic suspension), 0.1%, Alcon, NDA 13-422/S-035 CIPROFLOXACIN; DEXAMETHASONE Suspension/Drops; Otic 0.3%;0.1% CIPRODEX Alcon 088252 DEXAMETHASONE Concentrate; 1MG/ML DEXAMETHASONE INTENSOL Roxane 084754 DEXAMETHASONE Elixir; 0.5MG/5ML DEXAMETHASONE ALPHARMA 088254 DEXAMETHASONE Elixir; 0.5MG/5ML MYMETHASONE Morton Grove 012674 DEXAMETHASONE Elixir; 0.5MG/5ML HEXADROL ORGANON USA INC 088248 DEXAMETHASONE Solution; 0.5MG/5ML DEXAMETHASONE Roxane 013422 DEXAMETHASONE Suspension/Drops; Ophthalmic 0.1% MAXIDEX Alcon 011664 BP DEXAMETHASONE Tablet; 0.25MG DECADRON MERCK 011664 DEXAMETHASONE Tablet; 0.5MG DECADRON MERCK 011664 DEXAMETHASONE Tablet; 0.75MG DECADRON MERCK 011664 DEXAMETHASONE Tablet; 1.5MG DECADRON MERCK 011664 DEXAMETHASONE Tablet; 4MG DECADRON MERCK 011664 BP DEXAMETHASONE Tablet; 6MG DECADRON MERCK 012675 BP DEXAMETHASONE Tablet; 4MG HEXADROL ORGANON USA 088149 BP DEXAMETHASONE Tablet; 0.25MG DEXAMETHASONE Par 088148 BP DEXAMETHASONE Tablet; 0.5MG DEXAMETHASONE Par 088160 BP DEXAMETHASONE Tablet; 0.75MG DEXAMETHASONE Par 088237 BP DEXAMETHASONE Tablet; 1.5MG DEXAMETHASONE Par 088238 BP DEXAMETHASONE Tablet; 4MG DEXAMETHASONE Par 088481 BP DEXAMETHASONE Tablet; 6MG DEXAMETHASONE Par 084611 DEXAMETHASONE Tablet; 0.5MG DEXAMETHASONE Roxane 084613 DEXAMETHASONE Tablet; 0.75MG DEXAMETHASONE Roxane 084610 DEXAMETHASONE Tablet; 1.5MG DEXAMETHASONE Roxane 088306 DEXAMETHASONE Tablet; 1MG DEXAMETHASONE Roxane 087916 DEXAMETHASONE Tablet; 2MG DEXAMETHASONE Roxane 084612 DEXAMETHASONE Tablet; 4MG DEXAMETHASONE Roxane 088316 BP DEXAMETHASONE Tablet; 6MG DEXAMETHASONE Roxane 040491 DEXAMETHASONE SODIUM PHOSPHATE Injection 10MG PHOSPHATE/ML DEXAMETHASONE SODIUM PHOSPHATE AM 084916 DEXAMETHASONE SODIUM PHOSPHATE Injection 4MG PHOSPHATE/ML DEXAMETHASONE SODIUM PHOSPHATE AM PARTNERS 084282 DEXAMETHASONE SODIUM PHOSPHATE Injection 4MG PHOSPHATE/ML DEXAMETHASONE Baxter 087702 DEXAMETHASONE SODIUM PHOSPHATE Injection 10MG PHOSPHATE/ML DEXAMETHASONE ELKINS SINN 081126 DEXAMETHASONE SODIUM PHOSPHATE Injection 10MG PHOSPHATE/ML DEXAMETHASONE SODIUM PHOSPHATE Gensia Sicor 087440 DEXAMETHASONE SODIUM PHOSPHATE Injection 4MG PHOSPHATE/ML DEXAMETHASONE SODIUM PHOSPHATE LUITPOLD 088771 AT DEXAMETHASONE SODIUM PHOSPHATE Solution/Drops; Ophthalmic, Otic 0.1% PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE Alcon UNIVERSAL 040069 AT DEXAMETHASONE SODIUM PHOSPHATE Solution/Drops; Ophthalmic, Otic 0.1% PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE BAUSCH AND LOMB 011984 AT DEXAMETHASONE SODIUM PHOSPHATE Solution/Drops; Ophthalmic, Otic 0.1% PHOSPHATE DECADRON MERCK 064063 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE BAUSCH AND LOMB 050065 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM MAXITROL FALCON 062938 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE FOUGERA 062341 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML MAXITROL Alcon 062721 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE Alcon UNIVERSAL 064135 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML DEXASPORIN BAUSCH AND LOMB 050023 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML MAXITROL FALCON 062544 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML DEXACIDIN NOVARTIS 050616 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 Decadron (dexamethasone) Tablets, Merck & Co., Inc. Tobradex (tobramycin and dexamethasone ophthalmic ointment), Alcon Laboratories, Labeling Revision Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment), Falcon Pharmaceuticals, Labeling Revision | Dexamethasone Sodium Phosphate Injection, American Pharma, Approval

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