Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 009053
Company: STASON PHARMS

Products on NDA 009053

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

Showing 1 to 1 of 1 entries

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009053

Original Approvals or Tentative Approvals

CSV Excel Print

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
09/11/1953	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Showing 1 to 1 of 1 entries

Supplements

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Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
07/09/2024	SUPPL-44	Labeling-Package Insert	Label (PDF) Letter (PDF)
12/29/2020	SUPPL-40	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)
04/29/2020	SUPPL-39	Labeling-Package Insert	Label (PDF) Letter (PDF)
05/23/2018	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)
05/27/2011	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)
07/15/2004	SUPPL-24	Labeling	Label (PDF)
01/10/2003	SUPPL-22	Labeling	Label (PDF) Letter (PDF)
09/06/2002	SUPPL-21	Labeling	Letter (PDF)	Label is not available on this site.
03/22/2002	SUPPL-20	Labeling	Letter (PDF)	Label is not available on this site.
05/16/2001	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
04/03/2001	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
04/15/1996	SUPPL-18	Labeling		Label is not available on this site.
11/17/1987	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/20/1987	SUPPL-14	Labeling		Label is not available on this site.
04/09/1987	SUPPL-13	Labeling		Label is not available on this site.
10/14/1986	SUPPL-9	Labeling		Label is not available on this site.
09/23/1986	SUPPL-12	Labeling		Label is not available on this site.
11/20/1985	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
10/19/1982	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/19/1979	SUPPL-7	Labeling		Label is not available on this site.
02/15/1977	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.

Showing 1 to 21 of 21 entries

Labels for NDA 009053

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert
07/09/2024	SUPPL-44	Labeling-Package Insert	Label (PDF)
12/29/2020	SUPPL-40	Labeling-Container/Carton Labels	Label (PDF)
12/29/2020	SUPPL-40	Labeling-Package Insert	Label (PDF)
04/29/2020	SUPPL-39	Labeling-Package Insert	Label (PDF)
05/23/2018	SUPPL-35	Labeling-Package Insert	Label (PDF)
05/27/2011	SUPPL-32	Labeling-Package Insert	Label (PDF)
07/15/2004	SUPPL-24	Labeling	Label (PDF)
01/10/2003	SUPPL-22	Labeling	Label (PDF)

Showing 1 to 8 of 8 entries

Therapeutic Equivalents for NDA 009053

PURINETHOL

TABLET;ORAL; 50MG
TE Code = AB

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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
MERCAPTOPURINE	MERCAPTOPURINE	50MG	TABLET;ORAL	Prescription	No	AB	040594	MYLAN
PURINETHOL	MERCAPTOPURINE	50MG	TABLET;ORAL	Prescription	Yes	AB	009053	STASON PHARMS

Showing 1 to 4 of 4 entries