Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202872
Company: BAUSCH AND LOMB INC

• Summary Review

Products on NDA 202872

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOTEMAX	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202872

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2012	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202872lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202872Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202872_lotemax_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202872Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2018	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202872s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202872Orig1s002Ltr.pdf

Labels for NDA 202872

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2018	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202872s002lbl.pdf
09/28/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202872lbl.pdf

Therapeutic Equivalents for NDA 202872

LOTEMAX

GEL;OPHTHALMIC; 0.5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOTEMAX	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	Yes	AB	202872	BAUSCH AND LOMB INC
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	No	AB	213956	HIKMA
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	No	AB	212080	SENTISS
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	No	AB	215384	SUN PHARM