Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200655
Company: FEINSTEIN

Products on NDA 200655

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUORODOPA F18	FLUORODOPA F-18	1-40mCi/ML	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
FLUORODOPA F18	FLUORODOPA F-18	1-40mCi/ML	SOLUTION;INTRAVENOUS	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200655

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200655s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200655Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/200655Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2020	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/200655Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/200655Orig1s001ltr.pdf

Labels for NDA 200655

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2020	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/200655Orig1s001lbl.pdf
10/10/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200655s000lbl.pdf