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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202514
Company: THEA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIOPTAN TAFLUPROST 0.0015% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/10/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202514s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202514s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202514s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/04/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004ltr.pdf
09/04/2015 SUPPL-3 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004ltr.pdf
08/28/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/22/2013 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202514s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202514Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/04/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf
09/04/2015 SUPPL-3 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf
02/22/2013 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202514s001lbl.pdf
02/10/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202514s000lbl.pdf

ZIOPTAN

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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