Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214200
Company: G1 THERAP

Products on NDA 214200

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COSELA	TRILACICLIB DIHYDROCHLORIDE	EQ 300MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214200

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214200s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214200Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214200Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214200s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214200Orig1s006ltr.pdf
04/05/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214200s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214200Orig1s004ltr.pdf

Labels for NDA 214200

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214200s006lbl.pdf
04/05/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214200s004lbl.pdf
02/12/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214200s000lbl.pdf