Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205438
Company: HI TECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIFLURIDINE TRIFLURIDINE 1% 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
07/28/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

TRIFLURIDINE

SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIFLURIDINE TRIFLURIDINE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 205438 HI TECH
TRIFLURIDINE TRIFLURIDINE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074311 SANDOZ INC
VIROPTIC TRIFLURIDINE 1% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 018299 MONARCH PHARMS

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