Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091619
Company: SIGMAPHARM LABS LLC

Products on ANDA 091619

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DISULFIRAM	DISULFIRAM	250MG	TABLET;ORAL	Prescription	AB	No	No
DISULFIRAM	DISULFIRAM	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091619

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2011	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091619Orig1s000BioeqR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2016	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091619

DISULFIRAM

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DISULFIRAM	DISULFIRAM	250MG	TABLET;ORAL	Prescription	No	AB	091681	ALVOGEN
DISULFIRAM	DISULFIRAM	250MG	TABLET;ORAL	Prescription	No	AB	091563	CHARTWELL MOLECULES
DISULFIRAM	DISULFIRAM	250MG	TABLET;ORAL	Prescription	No	AB	091619	SIGMAPHARM LABS LLC

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DISULFIRAM	DISULFIRAM	500MG	TABLET;ORAL	Prescription	No	AB	091563	CHARTWELL MOLECULES
DISULFIRAM	DISULFIRAM	500MG	TABLET;ORAL	Prescription	No	AB	091619	SIGMAPHARM LABS LLC