Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020408
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRUSOPT DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
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
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
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

TRUSOPT

SOLUTION/DROPS;OPHTHALMIC; EQ 2% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 212639 ALEMBIC PHARMS LTD
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090143 BAUSCH AND LOMB
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 205294 FDC LTD
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077846 HI TECH PHARMA
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204778 MICRO LABS
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078748 SANDOZ INC
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078981 SANDOZ INC
TRUSOPT DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020408 MERCK

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