Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206319
Company: DECATUR

Products on ANDA 206319

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	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/13/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2018	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/22/2016	SUPPL-3	Labeling		Label is not available on this site.
03/26/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206319

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