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New Drug Application (NDA): 019463
Company: BAUSCH AND LOMB INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOPTIC IN OCUDOSE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT3 Yes Yes
TIMOPTIC IN OCUDOSE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT3 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
11/05/1986 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
04/06/2017 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019463s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019463Orig1s031ltr.pdf
08/14/2015 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
09/30/2011 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019463s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019463s028ltr.pdf
06/05/2006 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019463s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019463s027LTR.pdf
12/22/2003 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19463slr026_timoptic_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19463slr026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019463_s026_TimopticTOC.cfm
07/26/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
12/04/2001 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
12/07/2001 SUPPL-22 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19463s22lbl.pdf
03/02/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
03/02/2000 SUPPL-20 Labeling

Label is not available on this site.
03/18/1998 SUPPL-19 Labeling Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-463S019.pdf
06/22/1997 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
08/14/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
12/02/1996 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
12/02/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
04/22/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
05/16/1997 SUPPL-13 Labeling

Label is not available on this site.
07/10/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
01/18/1995 SUPPL-11 Labeling

Label is not available on this site.
12/09/1993 SUPPL-9 Labeling

Label is not available on this site.
03/25/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
05/21/1992 SUPPL-5 Labeling

Label is not available on this site.
05/21/1992 SUPPL-4 Labeling

Label is not available on this site.
07/09/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
08/09/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/06/2017 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019463s031lbl.pdf
09/30/2011 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019463s028lbl.pdf
06/05/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019463s027lbl.pdf
12/22/2003 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19463slr026_timoptic_lbl.pdf
12/07/2001 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19463s22lbl.pdf

TIMOPTIC IN OCUDOSE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT3

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 AT3 212592 AMRING PHARMS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT3 216533 INGENUS PHARMS LLC
TIMOPTIC IN OCUDOSE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT3 019463 BAUSCH AND LOMB INC

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT3

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 AT3 212291 AKORN
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT3 212592 AMRING PHARMS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT3 216533 INGENUS PHARMS LLC
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT3 216596 MICRO LABS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT3 217195 SENTISS PHARMA
TIMOPTIC IN OCUDOSE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT3 019463 BAUSCH AND LOMB INC
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