Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 200738
Company: BAUSCH AND LOMB

• Summary Review

Products on NDA 200738

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOTEMAX	LOTEPREDNOL ETABONATE	0.5%	OINTMENT;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200738

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2011	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/2011/200738s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200738s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200738_lotemax_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200738Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200738s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200738Orig1s003ltr.pdf

Labels for NDA 200738

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200738s003lbl.pdf
04/15/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200738s000lbl.pdf