Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017531
Company: KING PHARMS LLC
Company: KING PHARMS LLC
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TIGAN | TRIMETHOBENZAMIDE HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
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 |