Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208219
Company: BAUSCH AND LOMB INC

Products on NDA 208219

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOTEMAX SM	LOTEPREDNOL ETABONATE	0.38%	GEL;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208219

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208219s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208219Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208219Orig1s000TOC.html

Labels for NDA 208219

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208219s000lbl.pdf

Therapeutic Equivalents for NDA 208219

LOTEMAX SM

GEL;OPHTHALMIC; 0.38%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOTEMAX SM	LOTEPREDNOL ETABONATE	0.38%	GEL;OPHTHALMIC	Prescription	Yes	AB	208219	BAUSCH AND LOMB INC
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.38%	GEL;OPHTHALMIC	Prescription	No	AB	218087	LUPIN LTD