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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021201
Company: CHEMISCH FBRK KRSSLR

Summary Review

Products on NDA 021201

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASCLERA	POLIDOCANOL	10MG/2ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	No
ASCLERA	POLIDOCANOL	20MG/2ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021201

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2010	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021201s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021201s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021201s000_Sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2019	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021201s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021201Orig1s004ltr.pdf
03/01/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021201s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021201s002ltr.pdf

Labels for NDA 021201

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021201s004lbl.pdf
03/01/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021201s002lbl.pdf
03/30/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf

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