Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007517
Company: KING PHARMS

Products on NDA 007517

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAPAZOLE	METHIMAZOLE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
TAPAZOLE	METHIMAZOLE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 007517

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/1950	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
01/16/2001	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/007517s022lbl.pdf
11/17/1998	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
03/25/1998	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
04/02/1998	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/20/1995	SUPPL-18	Labeling		Label is not available on this site.
08/07/1992	SUPPL-17	Labeling		Label is not available on this site.
06/20/1991	SUPPL-16	Labeling		Label is not available on this site.
10/01/1991	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
12/07/2007	SUPPL-14	Labeling		Label is not available on this site.
02/27/1990	SUPPL-13	Labeling		Label is not available on this site.
11/13/1990	SUPPL-12	Labeling		Label is not available on this site.
12/07/2007	SUPPL-11	Labeling		Label is not available on this site.
12/07/2007	SUPPL-10	Labeling		Label is not available on this site.
09/24/1985	SUPPL-9	Labeling		Label is not available on this site.
02/25/1983	SUPPL-8	Labeling		Label is not available on this site.
12/07/2007	SUPPL-6	Labeling		Label is not available on this site.
12/07/2007	SUPPL-5	Labeling		Label is not available on this site.

Labels for NDA 007517

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2001	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/007517s022lbl.pdf