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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012429
Company: WAYLIS THERAP

Products on NDA 012429

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOGUANINE	THIOGUANINE	40MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012429

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/1966	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2018	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012429s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012429Orig1s028ltr.pdf
11/15/2004	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12429s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12429s022ltr.pdf
12/19/2003	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr021_tabloid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12429slr021ltr.pdf
06/30/2003	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr019_tabloid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12429slr019ltr.pdf
07/03/2002	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
12/12/2001	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12429s17ltr.pdf
07/15/1991	SUPPL-15	Labeling		Label is not available on this site.
04/05/1990	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/09/1987	SUPPL-13	Labeling		Label is not available on this site.
09/22/1986	SUPPL-12	Labeling		Label is not available on this site.
07/18/1988	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/20/1985	SUPPL-10	Labeling		Label is not available on this site.
08/06/1985	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/1984	SUPPL-8	Labeling		Label is not available on this site.
08/24/1978	SUPPL-7	Labeling		Label is not available on this site.
02/11/1977	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 012429

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2018	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012429s028lbl.pdf
11/15/2004	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12429s022lbl.pdf
12/19/2003	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr021_tabloid_lbl.pdf
06/30/2003	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12429slr019_tabloid_lbl.pdf

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