Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040528
Company: HIKMA

Products on ANDA 040528

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MERCAPTOPURINE	MERCAPTOPURINE	50MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040528

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/13/2004	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
06/26/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/22/2021	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
01/25/2021	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/25/2021	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
08/01/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/26/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040528

MERCAPTOPURINE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MERCAPTOPURINE	MERCAPTOPURINE	50MG	TABLET;ORAL	Prescription	No	AB	040461	DR REDDYS LABS SA
MERCAPTOPURINE	MERCAPTOPURINE	50MG	TABLET;ORAL	Prescription	No	AB	040528	HIKMA
PURINETHOL	MERCAPTOPURINE	50MG	TABLET;ORAL	Prescription	Yes	AB	009053	STASON PHARMS