Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020330
Company: VALEANT PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOPTIC-XE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription AB Yes Yes
TIMOPTIC-XE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription AB 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
11/04/1993 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/16/2018 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020330s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020330Orig1s032ltr.pdf
10/20/2015 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/08/2015 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020330s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020330Orig1s029ltr.pdf
09/30/2011 SUPPL-27 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020330s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020330s027ltr.pdf
04/26/2006 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020330s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020330s022, s024LTR.pdf
04/26/2006 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020330s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020330s022, s024LTR.pdf
08/11/2004 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20330s018,019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20330s018,019ltr.pdf
08/11/2004 SUPPL-18 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20330s018,019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20330s018,019ltr.pdf
12/22/2003 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20330slr017_timoptic_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20330slr017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020330_s017_TimopticTOC.cfm
12/04/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/03/2001 SUPPL-15 Labeling

Label is not available on this site.

09/18/2000 SUPPL-14 Labeling

Label is not available on this site.

06/07/1999 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1998 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-330S011.pdf
12/02/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/11/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/18/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1996 SUPPL-5 Labeling

Label is not available on this site.

04/25/1995 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/18/1995 SUPPL-3 Labeling

Label is not available on this site.

12/21/1994 SUPPL-2 Labeling

Label is not available on this site.

06/22/1994 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/16/2018 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020330s032lbl.pdf
10/08/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020330s029lbl.pdf
09/30/2011 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020330s027lbl.pdf
04/26/2006 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020330s022s024lbl.pdf
04/26/2006 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020330s022s024lbl.pdf
08/11/2004 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20330s018,019lbl.pdf
08/11/2004 SUPPL-18 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20330s018,019lbl.pdf
12/22/2003 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20330slr017_timoptic_lbl.pdf

TIMOPTIC-XE

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AB

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, GEL FORMING/DROPS;OPHTHALMIC Prescription No AB 020963 SANDOZ INC
TIMOPTIC-XE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription Yes AB 020330 VALEANT PHARMS LLC

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AB

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, GEL FORMING/DROPS;OPHTHALMIC Prescription No AB 020963 SANDOZ INC
TIMOPTIC-XE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription Yes AB 020330 VALEANT PHARMS LLC

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