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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203155
Company: MCPRF

Summary Review

Products on NDA 203155

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHOLINE C-11	CHOLINE C-11	4-33.1mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203155

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203155s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203155Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203155Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203155Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2014	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
09/09/2024	SUPPL-9	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203155s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203155Orig1s009ltr.pdf
10/28/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/30/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/30/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/26/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203155

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203155s009lbl.pdf
09/09/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203155s009lbl.pdf
09/12/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203155s000lbl.pdf

Therapeutic Equivalents for NDA 203155

CHOLINE C-11

INJECTABLE;INTRAVENOUS; 4-33.1mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHOLINE C-11	CHOLINE C-11	4-33.1mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	206319	DECATUR
CHOLINE C-11	CHOLINE C-11	4-33.1mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	203155	MCPRF

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