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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021623
Company: GALEN SPECIALTY

Products on NDA 021623

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYNERA	LIDOCAINE; TETRACAINE	70MG;70MG	PATCH;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021623

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2005	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021623lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021623ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021623TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2020	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021623s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021623Orig1s025ltr.pdf
11/02/2018	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021623s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021623Orig1s024ltr.pdf
01/10/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
07/09/2013	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
10/16/2013	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
03/10/2014	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017ltr.pdf
03/10/2014	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017ltr.pdf

Labels for NDA 021623

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2020	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021623s025lbl.pdf
11/02/2018	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021623s024lbl.pdf
03/10/2014	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf
03/10/2014	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf
06/23/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021623lbl.pdf

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