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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208073
Company: BAUSCH AND LOMB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XIIDRA LIFITEGRAST 5% SOLUTION/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
07/11/2016 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208073s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208073Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208073Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2020 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208073s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208073Orig1s005ltr.pdf
12/17/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208073s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208073Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/04/2020 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208073s005lbl.pdf
12/17/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208073s002lbl.pdf
07/11/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208073s000lbl.pdf

XIIDRA

SOLUTION/DROPS;OPHTHALMIC; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIFITEGRAST LIFITEGRAST 5% SOLUTION/DROPS;OPHTHALMIC Prescription No AB 215081 MICRO LABS
XIIDRA LIFITEGRAST 5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AB 208073 BAUSCH AND LOMB INC
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