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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020330
Company: BAUSCH AND LOMB INC

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 No
TIMOPTIC-XE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription AB Yes No

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
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