01 1ALLERGAN
02 1BRECKENRIDGE
03 1APOTEX
04 1CHARTWELL RX
05 1EPIC PHARMA LLC
06 1SANDOZ
07 1SOMERSET THERAPS LLC
08 1SUN PHARM INDS
01 7SOLUTION/DROPS;OPHTHALMIC
02 1SOLUTION; OPHTHALMIC
01 5DISCN
02 2RX
03 1Blank
01 1ELESTAT
02 7EPINASTINE HYDROCHLORIDE
01 6No
02 1Yes
03 1Blank
RLD : Yes
TE Code :
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Dosage Strength : 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2003-10-16
Application Number : 21565
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Approval Date : 2011-03-14
Application Number : 90870
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AT
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Approval Date : 2011-10-31
Application Number : 90919
RX/OTC/DISCN : RX
RLD : No
TE Code : AT
RLD : No
TE Code :
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Approval Date : 2016-12-07
Application Number : 203384
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Approval Date : 2017-05-05
Application Number : 204055
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD :
TE Code :
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION; OPHTHALMIC
Dosage Strength : 0.05%
Approval Date :
Application Number : 90950
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AT
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Approval Date : 2011-10-31
Application Number : 90951
RX/OTC/DISCN : RX
RLD : No
TE Code : AT
RLD : No
TE Code :
Brand Name : EPINASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Approval Date : 2011-10-31
Application Number : 91626
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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