Drugs@FDA: FDA-Approved Drugs
Company: MSD SUB MERCK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRUSOPT | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/09/1994 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/21/2020 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020408s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020408Orig1s052ltr.pdf | |
02/03/2014 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020408s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020408Orig1s050ltr.pdf | |
06/18/2010 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020408s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020408s047ltr.pdf | |
10/22/2008 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020408s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020408s045ltr.pdf | |
12/16/2005 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020408s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020408s039ltr.pdf | |
04/15/2004 | SUPPL-33 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20408se5-033_trusopt_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20408se5-033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020408_S033_TRUSOPT.pdf | |
12/06/2002 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/19/2002 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/15/2002 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408S25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20408s25ltr.pdf | |
04/15/2002 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/15/2002 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408s23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20408s23ltr.pdf | |
12/04/2001 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/18/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
01/18/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/15/2000 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
09/27/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
06/06/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
12/01/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
10/19/1998 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/03/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
12/12/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/03/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
08/03/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
06/13/1997 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/20/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/03/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
08/03/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
07/22/1996 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/31/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/31/1995 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/23/1995 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
04/25/1995 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/21/2020 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020408s052lbl.pdf | |
02/03/2014 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020408s050lbl.pdf | |
06/18/2010 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020408s047lbl.pdf | |
10/22/2008 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020408s045lbl.pdf | |
12/16/2005 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020408s039lbl.pdf | |
04/15/2004 | SUPPL-33 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20408se5-033_trusopt_lbl.pdf | |
05/15/2002 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408S25lbl.pdf | |
05/15/2002 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20408s23lbl.pdf |