Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.