01 3AbbVie Inc
02 1Allergan Aesthetics
03 2Apotex Inc
04 1Aurolab
05 1Brooks laboratories Limited
06 1Globela Pharma
07 1Hi-Tech Pharmacal Co Inc
08 1Hikma Pharmaceuticals
09 1Indiana Ophthalmics
10 1JAMP PHARMA
11 2Laboratorios Poen
12 1Lupin Ltd
13 1Rising Pharmaceuticals Inc
14 1Sandoz B2B
15 1Torrent Pharmaceuticals Limited
16 2Yangtze River Pharmaceutical Group
01 1Capsule
02 1Eye Dropes
03 1Eye Drops
04 1Eye/Ear Drop
05 1Injection
06 1OPD
07 2Ophthalmic Solution
08 3SOLUTION
09 8SOLUTION/DROPS;OPHTHALMIC
10 1SOLUTION; OPHTHALMIC
11 1Tablet
01 5DISCN
02 1Originator
03 3Prescription
04 3RX
05 9Blank
01 1APO-GATIFLOXACIN
02 1G-flox
03 7GATIFLOXACIN
04 1Gatidex
05 1Gatif Forte
06 1JAMP GATIFLOXACIN
07 2ZYMAR
08 1ZYMAXID
09 1Zymar
10 5Blank
01 2Argentina
02 3Canada
03 2China
04 4India
05 1South Africa
06 9USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZYMAXID
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2010-05-18
Application Number : 22548
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZYMAR
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.3%
Packaging :
Approval Date : 2003-03-28
Application Number : 21493
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ZYMAR
Dosage Form : SOLUTION
Dosage Strength : 0.3%/W/V
Packaging :
Approval Date :
Application Number : 2257270
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zymar
Dosage Form : OPD
Dosage Strength : 3mg/ml
Packaging : 5X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GATIFLOXACIN
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.3%
Packaging :
Approval Date : 2011-08-19
Application Number : 79084
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : APO-GATIFLOXACIN
Dosage Form : SOLUTION
Dosage Strength : 0.3%
Packaging : 5ML
Approval Date :
Application Number : 2327260
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : India
Brand Name : G-flox
Dosage Form : Eye Dropes
Dosage Strength : 0.3%/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Eye/Ear Drop
Dosage Strength : 0.3% W/V; 0.1% W/V
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 400MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : USA
Brand Name : GATIFLOXACIN
Dosage Form : SOLUTION; OPHTHALMIC
Dosage Strength : 0.3%
Packaging :
Approval Date :
Application Number : 203190
Regulatory Info :
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GATIFLOXACIN
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2014-09-03
Application Number : 203189
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Eye Drops
Dosage Strength : 0.3%/W/V
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Argentina
Brand Name : Gatidex
Dosage Form : Ophthalmic Solution
Dosage Strength : 0.1%; 0.3%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Argentina
Regulatory Info :
Registration Country : Argentina
Brand Name : Gatif Forte
Dosage Form : Ophthalmic Solution
Dosage Strength : 0.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Argentina
Regulatory Info : RX
Registration Country : USA
Brand Name : GATIFLOXACIN
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2013-08-28
Application Number : 202653
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GATIFLOXACIN
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2018-06-08
Application Number : 206446
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GATIFLOXACIN
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2016-07-11
Application Number : 204227
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GATIFLOXACIN
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2021-11-03
Application Number : 213542
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Capsule
Dosage Strength : 200MG
Packaging : 200mgx6caps; 200mgx12caps
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 200MG
Packaging : 100mL:200mg
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
