Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020869
Company: THEA PHARMA
Company: THEA PHARMA
| 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 | AT1 | 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.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/23/2020 | SUPPL-42 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020869s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020869Orig1s042ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 11/23/2020 | SUPPL-42 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020869s042lbl.pdf | |
| 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 = AT1
| 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 | AT1 | 020869 | THEA PHARMA |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 213099 | ALEMBIC |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 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 | AT1 | 203058 | EPIC PHARMA LLC |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 207629 | EUGIA PHARMA |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 205295 | FDC LTD |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 215520 | GLAND |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 204777 | MICRO LABS |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 202054 | REGCON HOLDINGS |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 078749 | SANDOZ |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 090604 | SANDOZ |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 207523 | SOMERSET |