Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020963
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription AB No No
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription AB No 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
10/21/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20963lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20963ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020963_timolol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/08/2007 SUPPL-10 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020963s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020963s010ltr.pdf
07/02/2003 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20963slr007_droptainer_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20963slr007ltr.pdf
02/05/2001 SUPPL-5 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20963s5lbl.pdf
03/09/2000 SUPPL-4 Labeling

Label is not available on this site.

02/18/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/17/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1999 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
06/08/2007 SUPPL-10 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020963s010lbl.pdf
07/02/2003 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20963slr007_droptainer_lbl.pdf
02/05/2001 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20963s5lbl.pdf
10/21/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20963lbl.pdf

TIMOLOL MALEATE

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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