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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017530
Company: PH HEALTH

Products on NDA 017530

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIGAN	TRIMETHOBENZAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017530

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
04/18/2008	SUPPL-24	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017530s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017530s024ltr.pdf
08/26/2005	SUPPL-23	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017530s021,022,023ltr.pdf
08/26/2005	SUPPL-22	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017530s021,022,023ltr.pdf
08/26/2005	SUPPL-21	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017530s021,022,023ltr.pdf
06/28/2002	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/30/2002	SUPPL-18	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17529s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017530_S018_TIGAN_AP.pdf
02/23/2001	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/14/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/28/1999	SUPPL-15	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
10/22/1999	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/03/1998	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/20/1986	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
09/15/1981	SUPPL-8	Labeling		Label is not available on this site.
09/25/1980	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/18/1975	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/12/1975	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 017530

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2008	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017530s024lbl.pdf
08/26/2005	SUPPL-23	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf
08/26/2005	SUPPL-22	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf
08/26/2005	SUPPL-21	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017530s021,022,023lbl.pdf
04/30/2002	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531s10lbl.pdf

Therapeutic Equivalents for NDA 017530

TIGAN

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIGAN	TRIMETHOBENZAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017530	PH HEALTH
TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	219606	BPI LABS

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