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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208073
Company: BAUSCH AND LOMB INC

Products on NDA 208073

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XIIDRA	LIFITEGRAST	5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208073

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

Labels for NDA 208073

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

Therapeutic Equivalents for NDA 208073

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	215063	EUGIA PHARMA
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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