Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206679
Company: TCG FLUENT PHARMA

• Summary Review

Products on NDA 206679

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLOLIPID	SIMVASTATIN	20MG/5ML	SUSPENSION;ORAL	Prescription	None	Yes	No
FLOLIPID	SIMVASTATIN	40MG/5ML	SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206679

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2016	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206679s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206679Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206679Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206679Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206679s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206679Orig1s003ltr.pdf
10/04/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206679s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206679Orig1s002ltr.pdf

Labels for NDA 206679

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206679s003lbl.pdf
10/04/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206679s002lbl.pdf
04/21/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206679s000lbl.pdf