01 2AbbVie Inc
02 3Allergan Aesthetics
03 1Breckenridge Pharmaceutical
04 1Apotex Inc
05 1Chartwell Pharmaceuticals llc
06 1Epic Pharma. LLC.
07 1Hanlim Pharmaceuticals Inc
08 1Indiana Ophthalmics
09 1Jeil Pharmaceutical Co., Ltd
10 1Sandoz B2B
11 1Somerset Pharmaceuticals Inc
12 1Sun Pharmaceutical Industries Limited
01 1EYE DROP
02 1EYE DROPS, SOLUTION
03 1Eye Drops
04 1Gtt Opht
05 1OPD
06 7SOLUTION/DROPS;OPHTHALMIC
07 1SOLUTION; OPHTHALMIC
08 1TABLET
09 1Blank
01 4DISCN
02 2Generic
03 1Originator
04 3RX
05 5Blank
01 1ELESTAT
02 7EPINASTINE HYDROCHLORIDE
03 1EPINATIN
04 4Relestat
05 2Blank
01 1India
02 1Italy
03 1South Africa
04 2South Korea
05 1Sweden
06 1Switzerland
07 8USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Relestat
Dosage Form : Gtt Opht
Dosage Strength : 0.05%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ELESTAT
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2003-10-16
Application Number : 21565
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Packaging :
Approval Date : 2011-03-14
Application Number : 90870
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Relestat
Dosage Form : OPD
Dosage Strength : 10mg/ml
Packaging : 5X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Sweden
Brand Name : Relestat
Dosage Form : EYE DROPS, SOLUTION
Dosage Strength : 0.5 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Relestat
Dosage Form :
Dosage Strength : Coll 5 Ml 0,5 Mg/Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : RX
Registration Country : USA
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Packaging :
Approval Date : 2011-10-31
Application Number : 90919
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Packaging :
Approval Date : 2016-12-07
Application Number : 203384
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Packaging :
Approval Date : 2017-05-05
Application Number : 204055
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Generic
Registration Country : South Korea
Brand Name : EPINATIN
Dosage Form : EYE DROP
Dosage Strength : 0.5MG
Packaging : 0.3mL,10ea
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Eye Drops
Dosage Strength : 0.05%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : Generic
Registration Country : South Korea
Brand Name :
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Regulatory Info :
Registration Country : USA
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION; OPHTHALMIC
Dosage Strength : 0.05%
Packaging :
Approval Date :
Application Number : 90950
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Packaging :
Approval Date : 2011-10-31
Application Number : 90951
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Packaging :
Approval Date : 2011-10-31
Application Number : 91626
Regulatory Info : DISCN
Registration Country : USA
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