Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091563
Company: CHARTWELL MOLECULES

Products on ANDA 091563

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091563

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091563

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