Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017530
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIGAN TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription None Yes Yes
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.

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

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