Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018086
Company: VALEANT PHARMS INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOPTIC TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes No
TIMOPTIC TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT1 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
08/17/1978 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
08/09/2016 SUPPL-76 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018086s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018086Orig1s076ltr.pdf
09/30/2011 SUPPL-75 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018086s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018086s075ltr.pdf
04/26/2006 SUPPL-72 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018086s070,s072ltr.pdf
04/26/2006 SUPPL-70 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018086s070,s072ltr.pdf
12/06/2002 SUPPL-62 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/2003 SUPPL-60 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18086scs060_timoptic_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18086scs060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018086_s060_TimopticTOC.cfm
04/17/2002 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/2002 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18086s58lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18086s058.pdf
12/05/2001 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

11/30/2001 SUPPL-56 Labeling

Label is not available on this site.

04/12/2001 SUPPL-54 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18086S54lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18086S54ltr.pdf
09/18/2000 SUPPL-53 Labeling

Label is not available on this site.

03/18/1998 SUPPL-52 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-086S052.pdf
08/05/1997 SUPPL-51 Labeling

Label is not available on this site.

12/02/1996 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1998 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

04/16/1996 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

05/16/1997 SUPPL-47 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-086S047.pdf
07/18/1996 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1995 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1995 SUPPL-44 Labeling

Label is not available on this site.

02/24/1995 SUPPL-43 Labeling

Label is not available on this site.

12/09/1993 SUPPL-42 Labeling

Label is not available on this site.

05/20/1992 SUPPL-38 Labeling

Label is not available on this site.

05/20/1992 SUPPL-37 Labeling

Label is not available on this site.

03/19/1990 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1992 SUPPL-35 Labeling

Label is not available on this site.

01/15/1988 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/04/1987 SUPPL-33 Labeling

Label is not available on this site.

08/04/1987 SUPPL-32 Labeling

Label is not available on this site.

11/28/1986 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/05/1987 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1986 SUPPL-29 Labeling

Label is not available on this site.

08/04/1987 SUPPL-28 Labeling

Label is not available on this site.

11/29/1984 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/12/1986 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/14/1984 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/07/1983 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/03/1981 SUPPL-18 Labeling

Label is not available on this site.

10/27/1981 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/09/1981 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1981 SUPPL-15 Labeling

Label is not available on this site.

08/04/1987 SUPPL-14 Labeling

Label is not available on this site.

03/31/1981 SUPPL-13 Labeling

Label is not available on this site.

07/15/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/20/1980 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1980 SUPPL-10 Labeling

Label is not available on this site.

02/11/1980 SUPPL-9 Labeling

Label is not available on this site.

05/13/1980 SUPPL-7 Labeling

Label is not available on this site.

07/20/1979 SUPPL-6 Labeling

Label is not available on this site.

12/03/1979 SUPPL-5 Labeling

Label is not available on this site.

04/06/1979 SUPPL-4 Labeling

Label is not available on this site.

01/02/1980 SUPPL-2 Labeling

Label is not available on this site.

01/08/1980 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2016 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018086s076lbl.pdf
09/30/2011 SUPPL-75 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018086s075lbl.pdf
04/26/2006 SUPPL-72 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf
04/26/2006 SUPPL-70 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf
12/22/2003 SUPPL-60 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18086scs060_timoptic_lbl.pdf
04/29/2002 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18086s58lbl.pdf
04/12/2001 SUPPL-54 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18086S54lbl.pdf

TIMOPTIC

SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074778 BAUSCH AND LOMB
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077259 FDC LTD
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074746 PACIFIC PHARMA
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074261 SANDOZ INC
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078771 WOCKHARDT
TIMOPTIC TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 018086 VALEANT PHARMS INTL

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074466 AKORN
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074516 AKORN
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074776 BAUSCH AND LOMB
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 077259 FDC LTD
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 075163 HI TECH PHARMA
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074747 PACIFIC PHARMA
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 074262 SANDOZ INC
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 078771 WOCKHARDT
TIMOPTIC TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT1 018086 VALEANT PHARMS INTL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English