Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212155
Company: GE HEALTHCARE

Products on NDA 212155

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CERIANNA	FLUOROESTRADIOL F-18	50ML (4-100mCi/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212155

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/20/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212155s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212155Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212155Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2022	SUPPL-14	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 212155

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212155s000lbl.pdf