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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018086
Company: BAUSCH AND LOMB INC

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 AT1 Yes No
TIMOPTIC TIMOLOL MALEATE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT1 Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/17/2021 SUPPL-80 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018086Orig1s080lbl.pdf
11/17/2021 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018086Orig1s080lbl.pdf
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
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