Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078242
Company: SUN PHARM INDS INC

Products on ANDA 078242

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECHNETIUM TC-99M MEBROFENIN	TECHNETIUM TC-99M MEBROFENIN KIT	N/A	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078242

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078242ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/12/2010	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078242

TECHNETIUM TC-99M MEBROFENIN

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