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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206220
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BEPOTASTINE BESILATE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS;OPHTHALMIC Prescription AT No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/18/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

BEPOTASTINE BESILATE

SOLUTION/DROPS;OPHTHALMIC; 1.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BEPOTASTINE BESILATE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206066 APOTEX
BEPOTASTINE BESILATE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206220 MYLAN
BEPREVE BEPOTASTINE BESILATE 1.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 022288 BAUSCH AND LOMB INC
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