Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020869
Company: OAK PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COSOPT DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% 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
04/07/1998 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20869lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20869ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020869_cosopt_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2015 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020869s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020869Orig1s040ltr.pdf
06/18/2010 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020869s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020869s036ltr.pdf
10/22/2008 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020869s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020869s034ltr.pdf
08/09/2006 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s030LTR.pdf
04/26/2006 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s026, s028LTR.pdf
04/26/2006 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s026, s028LTR.pdf
12/09/2005 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020869s022ltr.pdf
03/28/2005 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020869s020ltr.pdf
12/06/2002 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/23/2002 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20869s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20869s012.pdf
08/28/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/04/2001 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/24/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/19/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/2000 SUPPL-6 Labeling

Label is not available on this site.

11/21/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/23/2000 SUPPL-3 Labeling

Label is not available on this site.

11/09/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1999 SUPPL-1 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-869-s-001_cosopt.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/31/2015 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020869s040lbl.pdf
06/18/2010 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020869s036lbl.pdf
10/22/2008 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020869s034lbl.pdf
08/09/2006 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s030lbl.pdf
04/26/2006 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s026s028lbl.pdf
04/26/2006 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s026s028lbl.pdf
12/09/2005 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s022lbl.pdf
03/28/2005 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s020lbl.pdf
04/23/2002 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20869s12lbl.pdf
04/07/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20869lbl.pdf

COSOPT

SOLUTION/DROPS;OPHTHALMIC; EQ 2% BASE;EQ 0.5% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COSOPT DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020869 OAK PHARMS INC
COSOPT PF DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 202667 OAK PHARMS INC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203058 AKORN INC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 207523 ANDA REPOSITORY
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 207630 AUROBINDO PHARMA LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090037 BAUSCH AND LOMB
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 205295 FDC LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077847 HI TECH PHARMA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078749 SANDOZ
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090604 SANDOZ INC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078704 TEVA PHARMS

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