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… Tequin (Gatifloxacin) Tablets, Injection & Dextrose Injection, Bristol-Myers Squibb NDA 21-061/S11, 21-061/S15 & 21-062/S15 12/19/02 1/29/03 4/7/03 Tequin (Gatifloxacin) Tablets & Injection, Bristol-Myers Squibb NDA 21-061/S8/S9/S12 10/31/01 05/08/03 Tequin (Gatifloxacin) Tablets & Injection, Bristol-Myers Squibb NDA 21-061/S7 NDA 21-062/S8 10/12/01 6/19/02 6/19/02 6/19/02 Tequin (Gatifloxacin) Tablets & Injection, Bristol-Myers Squibb NDA 21-062/S9/S10/S12 10/31/01 05/8/03 Tequin (Gatifloxacin) Tablets & Injection, Bristol-Myers Squibb NDA 21-062/S6/S7 08/20/01 05/08/03 Tequin (Gatifloxacin) Tablets & Injection, Bristol-Myers Squibb NDA 21-061/S5/S6 08/20/01 05/08/03 Tequin (Gatifloxacin) Tablets & Injection, Bristol-Myers Squibb NDA 21-404, 21-405, 21-061/S-010, 21-062/S-011, 21-061/S-016 & 21-062/S-017 10/17/02 10/21/02 10/18/02 Tequin (Gatifloxacin) Tablets & IV, 200 and 400mg / IV-10mg/mL vials and 2mg/mL flexible containers, Bristol-Myers Squibb NDA 21-061 NDA 21-062 12/17/99 12/27/99 12/27/99 7/18/01 Tequin (Gatifloxacin) Indications: 1. Acute Bacterial Sinusitis, 2. Community Acquired Pneumonia, 3. Acute Bacterial Exacerbation Chronic Bronchitis, 4. Uncomplicated Urinary Tract Infections, 5. Complicated Urinary Tract Infections, 6. Pyelonephritis, 7. Uncomplicated Gonorrhea Zymar (gatifloxacin) ophthalmic solution, 0.3% Allergan, NDA 21-493 GATIFLOXACIN Injection 10MG /ML(200MG) TEQUIN BRISTOL MYERS SQUIBB 021062 GATIFLOXACIN Injection 10MG /ML(400MG) TEQUIN BRISTOL MYERS SQUIBB 021062 GATIFLOXACIN Injection 2MG /ML(200MG/100ML) TEQUIN BRISTOL MYERS SQUIBB 021062 GATIFLOXACIN Injection 2MG /ML(400MG/200ML) TEQUIN BRISTOL MYERS SQUIBB 021493 GATIFLOXACIN Solution/Drops; Ophthalmic 0.3% ZYMAR ALLERGAN 021061 GATIFLOXACIN Tablet; 200MG TEQUIN BRISTOL MYERS SQUIBB 021061 GATIFLOXACIN Tablet; 400MG TEQUIN BRISTOL MYERS SQUIBB Tequin (Gatifloxacin) Tablets, Injection, Bristol-Myers Squibb TEQUIN (gatifloxacin) Injection and TEQUIN (gatifloxacin in 5% Dextrose) Injection, Bristol-Myers Squibb, New or Modified Indication TEQUIN (gatifloxacin) Tablets, Bristol-Myers Squibb, New or Modified Indication Tequin (gatifloxacin) for Oral Suspension, Bristol-Myers Squibb, Approval   For the latest approval information, locate this drug using this index.