Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203431
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAVOPROST TRAVOPROST 0.004% 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
07/10/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203431Orig1s000ltr.pdf

TRAVOPROST

SOLUTION/DROPS;OPHTHALMIC; 0.004%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAVATAN Z TRAVOPROST 0.004% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021994 NOVARTIS
TRAVOPROST TRAVOPROST 0.004% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203431 APOTEX
TRAVOPROST TRAVOPROST 0.004% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 205050 MYLAN

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