Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017531
Company: KING PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIGAN TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE;ORAL Prescription AB 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
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.

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

TIGAN

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIGAN TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE;ORAL Prescription Yes AB 017531 KING PHARMS LLC
TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE;ORAL Prescription No AB 076546 LUPIN
TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE;ORAL Prescription No AB 076570 SUN PHARM INDUSTRIES

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