Drugs@FDA: FDA-Approved Drugs
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 |