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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207695
Company: ANACOR PHARMS INC

Products on NDA 207695

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EUCRISA	CRISABOROLE	2%	OINTMENT;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207695

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2016	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207695s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207695Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207695Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2023	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207695s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207695Orig1s012ltr.pdf
03/23/2020	SUPPL-10	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207695Orig1s007, s009, s010ltr.pdf
03/23/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207695Orig1s007, s009, s010ltr.pdf
03/23/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207695Orig1s007, s009, s010ltr.pdf
10/16/2017	SUPPL-2	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207695s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207695Orig1s002ltr.pdf

Labels for NDA 207695

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2023	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207695s012lbl.pdf
03/23/2020	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf
03/23/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf
03/23/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf
10/16/2017	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207695s002lbl.pdf
12/14/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207695s000lbl.pdf

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