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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209051
Company: MICRO LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAFLUPROST TAFLUPROST 0.0015% 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
08/19/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209051Orig1s000ltr.pdf

TAFLUPROST

SOLUTION/DROPS;OPHTHALMIC; 0.0015%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TAFLUPROST TAFLUPROST 0.0015% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209051 MICRO LABS
TAFLUPROST TAFLUPROST 0.0015% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209040 SANDOZ INC
ZIOPTAN TAFLUPROST 0.0015% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 202514 THEA PHARMA
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