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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017531
Company: KING PHARMS LLC

Products on NDA 017531

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIGAN	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017531

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/1974	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2017	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017531s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017531Orig1s014ltr.pdf
12/02/2008	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017531s013ltr.pdf
03/24/2008	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017531s012ltr.pdf
12/13/2001	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531S010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17531S010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017531_S010_TIGAN_CAPSULE_AP.pdf
09/15/1981	SUPPL-6	Labeling		Label is not available on this site.
05/23/1975	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 017531

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017531s014lbl.pdf
12/02/2008	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s013lbl.pdf
03/24/2008	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s012lbl.pdf
12/13/2001	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531S010lbl.pdf

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