Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018963
Company: BRACCO

Products on NDA 018963

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHOLETEC	TECHNETIUM TC-99M MEBROFENIN KIT	N/A	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018963

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/1987	ORIG-1	Approval	Type 1 - New Molecular Entity	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
09/10/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/19/2007	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
07/01/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/19/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/24/1993	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for NDA 018963

CHOLETEC

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHOLETEC	TECHNETIUM TC-99M MEBROFENIN KIT	N/A	INJECTABLE;INJECTION	Prescription	Yes	AP	018963	BRACCO
TECHNETIUM TC-99M MEBROFENIN	TECHNETIUM TC-99M MEBROFENIN KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	078242	SUN PHARM INDS INC