FDA Approval Activities for this Drug…

Floxin (Ofloxacin) Otic Solution, Daiichi Pharmaceutical NDA 20-799/S12 10/7/03 10/9/03 10/10/03 Floxin (Ofloxacin) Otic Solution, Daiichi Pharmaceutical NDA 20-799/S-006 9/30/03 10/9/03 10/10/03 Floxin (Ofloxacin) Otic Solution, Daiichi Pharmaceutical NDA 20-799 Ofloxacin Injection, 40 mg/mL packaged in 10 mL single dose vials, Bedford ANDA 75-762 1/16/02 Ofloxacin Injection, 40 mg/mL packaged in 10 mL single dose vials, Bedford ANDA 75-762 5/23/01 6/5/01 Ofloxacin Ophthalmic Solution USP, 0.3%, Novex Pharma ANDA 76-513 10/22/03 Ofloxacin Ophthalmic Solution USP, 0.3%, Alcon Universal, Ltd. ANDA 76-231 5/13/02 Ofloxacin Tablets, 200, 300 & 400 mg, Ranbaxy ANDA 76-220 9/2/03 Ofloxacin Tablets, 200, 300 & 400 mg, Teva ANDA 76-182 9/2/03 Ofloxacin Tablets, 200, 300 & 400 mg, Teva ANDA 76-182 11/23/01 4/16/03 Ofloxacin Tablets, 200, 300 & 400 mg, Ofloxacin Tablets, Par Pharmaceutical ANDA 76-093 9/2/03 Ofloxacin Tablets, 200, 300 & 400 mg, Par Pharmaceutical, ANDA 76-093 Ofloxacin Ophthalmic Solution USP, Novex Pharma, OFLOXACIN Injection 40MG/ML OFLOXACIN Bedford 020087 OFLOXACIN Injection 400MG/100ML FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ORTHO MCNEIL 020087 OFLOXACIN Injection 400MG/100ML FLOXIN IN DEXTROSE 5% ORTHO MCNEIL 020087 OFLOXACIN Injection 40MG/ML FLOXIN ORTHO MCNEIL 019921 OFLOXACIN Solution/Drops; Ophthalmic 0.3% OCUFLOX ALLERGAN 020799 OFLOXACIN Solution/Drops; Otic 0.3% FLOXIN DAIICHI 019735 OFLOXACIN Tablet; 200MG FLOXIN ORTHO MCNEIL 019735 OFLOXACIN Tablet; 300MG FLOXIN ORTHO MCNEIL 019735 OFLOXACIN Tablet; 400MG FLOXIN ORTHO MCNEIL 076093 OFLOXACIN Tablet; 200MG OFLOXACIN Par 076093 OFLOXACIN Tablet; 300MG OFLOXACIN Par 076093 OFLOXACIN Tablet; 400MG OFLOXACIN Par 076220 OFLOXACIN Tablet; 200MG OFLOXACIN Ranbaxy 076220 OFLOXACIN Tablet; 300MG OFLOXACIN Ranbaxy 076220 OFLOXACIN Tablet; 400MG OFLOXACIN Ranbaxy 076182 OFLOXACIN Tablet; 200MG OFLOXACIN Teva 076182 OFLOXACIN Tablet; 300MG OFLOXACIN Teva 076182 OFLOXACIN Tablet; 400MG OFLOXACIN Teva Ofloxacin Ophthalmic Solution USP, Bausch & Lomb, Floxin (Ofloxacin) Otic Solution, Daiichi Pharmaceutical Floxin (Ofloxacin) Tablets, R.W. Johnson Pharmaceutical Ofloxacin Ophthalmic Solution USP, Hi-Tech Pharmacal, Ofloxacin Ophthalmic Solution USP, Alcon Research Ofloxacin Ophthalmic Solution USP, Bausch & Lomb, Inc. Ofloxacin Ophthalmic Solution USP, Hi-Tech Pharmacal Ofloxacin Ophthalmic Solution USP, Novex Pharma Ofloxacin Ophthalmic Solution, Pharmaforce, Approval | FLOXIN (ofloxacin tablets) Tablets, Johnson & Johnson, Labeling Revision | FLOXIN (Ofloxacin) Otic Solution, Daiichi Pharma, Labeling Revision

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