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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021717
Company: CRESCITA THERAP

Products on NDA 021717

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PLIAGLIS	LIDOCAINE; TETRACAINE	7%;7%	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021717

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2006	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021717lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021717s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021717_tradename_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021717Orig1s011ltr.pdf
12/11/2018	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021717Orig1s010ltr.pdf
11/21/2017	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021717s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021717Orig1s009ltr.pdf
03/09/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/07/2013	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021717s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021717Orig1s005ltr.pdf
06/28/2007	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021717s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021717s002_ltr.pdf

Labels for NDA 021717

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2018	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s010lbl.pdf
12/11/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s010lbl.pdf
11/02/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s011lbl.pdf
11/21/2017	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021717s009lbl.pdf
11/21/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021717s009lbl.pdf
11/07/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021717s005lbl.pdf
06/28/2007	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021717s002lbl.pdf
06/29/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021717lbl.pdf

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