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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202514
Company: THEA PHARMA

Products on NDA 202514

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202514

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

Labels for NDA 202514

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

Therapeutic Equivalents for NDA 202514

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	218002	INGENUS PHARMS LLC
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
ZIOPTAN	TAFLUPROST	0.0015%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	202514	THEA PHARMA

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