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GATIFLOXACIN

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

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 | Tequin (gatifloxacin in 5% dextrose) Injection, Bristol Myers-Squibb, Labeling Revision | | Tequin (gatifloxacin) Tablets, Bristol Myers-Squibb, Labeling Revision | Zymar (gatifloxacin) ophthalmic solution, Allergan, Package Change & Labeling Revision | Gatifloxacin Tablets, Teva Pharma, Tentative Approval | Gatifloxacin Tablets, Zydus Pharma, Tentative Approval | TEQUIN (gatifloxacin) Tablet, Bristol-Myers Squibb, Labeling Revision | TEQUIN (gatifloxacin) I.V., Bristol-Myers Squibb, Labeling Revision | TEQUIN (gatifloxacin) Powder, Bristol-Myers Squibb, Labeling Revision | Tequin (gatifloxacin) Tablets, Bristol Myers-Squibb, Labeling Revision | Tequin (gatifloxacin dextrose) Injection, Bristol Myers-Squibb, Labeling Revision | Tequin (gatifloxacin HCL) Oral Suspension, Bristol Myers-Squibb, Labeling Revision | Zymaxid (gatifloxacin) Ophthalmic Solution, Allergan, Inc., Approval | Gatifloxacin Ophthalmic Solution, Apotex Corp., Approval | Gatifloxacin, gatifloxacin, Solution; Ophthalmic, Lupin Ltd, Tentative Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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