FDA Approval Activities for this Drug…

Levaquin, RW Johnson NDA 20-634, S004 & 20-635, S003 12/17/98 7/2/99 Levaquin Indications: uncomplicated urinary tract infection (UTI) Levaquin (levofloxacin) Tablets & Injection, Johnson & Johnson Pharmaceutical NDA 20-634/S28 & 20-635/S27 10/23/03 Levaquin (levofloxacin) Tablets & Injection, R.W. Johnson Pharmaceutical Research Institute NDA 20-634/S25 & 20-635/S22 10/30/02 1/29/03 10/31/02 Levaquin (levofloxacin) Tablets & Injection, R.W. Johnson Pharmaceutical Research Institute NDA 20-634/S15, S21 & S22 & 20-635/S12, S19 & S20 12/18/01 2/12/01 2/12/01 Levaquin (levofloxacin) Tablets & Injection, 250mg, 500mg, & 750mg / IV - 25mg/mL; 20 & 30mL(new) vials 5mg/mL; 50, 100, & 150mL(new), R.W. Johnson Pharmaceutical Research Institute NDA 20-634/S-013 & 20-635/S-010 9/8/00 9/12/00 9/12/00 Levaquin Indication: Treatment of complicated skin and skin structure infections. Levaquin Tablets,250mg and 500mg / Levaquin Injection,25mg/ml and 5mg/ml, R.W. Johnson Pharmaceutical Research Institute NDA 20-634/S-008 & 20-635/S-007 2/2/00 2/3/00 Levaquin Indication: Treatment of levofloxacin-susceptible strains of penicillin-resistant Steptococcus pneumoniae in patients with community acquired pneumonia. Quixin (levofloxacin ophthalmic solution), 0.5%, Santen Incorporated NDA 21-199/S3 6/4/02 6/17/02 6/7/02 Quixin (levofloxacin ophthalmic solution), 0.5%, Santen Incorporated NDA 21-199/S2 4/18/02 4/22/02 4/18/02 Quixin (levofloxacin ophthalmic solution) Sterile, 0.5%, Santen Incorporated NDA 21-199 8/18/00 8/28/00 8/28/00 Quixin Indications: treatment of bacterial conjunctivitis. Levaquin (levofloxacin) Tablets & Injection, Johnson & Johnson Pharmaceutical LEVOFLOXACIN Injection 25MG/ML LEVAQUIN ORTHO MCNEIL 020635 LEVOFLOXACIN Injection 500MG/100ML LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER ORTHO MCNEIL 020635 LEVOFLOXACIN Injection 5MG/ML LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER ORTHO MCNEIL 021199 LEVOFLOXACIN Solution/Drops; Ophthalmic 0.5% QUIXIN SANTEN 020634 LEVOFLOXACIN Tablet; 250MG LEVAQUIN ORTHO MCNEIL 020634 LEVOFLOXACIN Tablet; 500MG LEVAQUIN ORTHO MCNEIL 020634 LEVOFLOXACIN Tablet; 750MG LEVAQUIN ORTHO MCNEIL Iquix (Levofloxacin) Opthalmic Solution, Santen Incorporated Levaquin (levofloxacin) Tablets & Injection, R.W. Johnson Pharmaceutical Levofloxacin Tablets, Teva Pharmaceuticals, Levofloxacin Injection, Bedford Laboratories | Levofloxacin Tablets, Ranbaxy, Inc., Tentative Approval | LEVAQUIN (levofloxacin) Injection, R.W. Johnson Pharmaceutical, Labeling Revision | LEVAQUIN (levofloxacin) Tablets R.W. Johnson Pharmaceutical, Labeling Revision | Levofloxacin Tablets, Myland Pharma, Approval | Levaquin (Levofloxacin) Oral Solution, J & J Pharmaceuticals, Approval | LEVAQUIN (levofloxacin) Tablets, Ortho McNeil Pharma, Labeling Revision | LEVAQUIN (levofloxacin) Injection, Ortho McNeil Pharma, Labeling Revision | Levaquin (Levofloxacin) Tablets, Ortho-McNeil, New or Modified Indication | Levaquin (Levofloxacin) Injection, Ortho-McNeil, New or Modified Indication | Levaquin (Levofloxacin) Oral Solution, Ortho-McNeil, New or Modified Indication | Levofloxacin Tablet (750mg), Teva Pharma, Approval | Levofloxacin Injection, Sicor Pharma, Tentative Approval | Levofloxacin Tablets, Mylan Pharma, Tentative Approval | Levofloxacin Ophthalmic Solution, Hi-Tech Pharmacal, Tentative Approval | Quixin (levofloxacin ophthalmic solution), Santen Inc., Labeling Revision & Package Change | Levofloxacin Tablets, Dr. Reddy's Labs, Tentative Approval

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