An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020583
Company: BAUSCH AND LOMB

Products on NDA 020583

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020583

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/1998	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20583lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20583ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20583_Lotemax.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2013	SUPPL-28	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020583Orig1s028.pdf
10/09/2013	SUPPL-27	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020583Orig1s027.pdf
07/11/2006	SUPPL-13	Labeling-Container/Carton Labels		Label is not available on this site.
08/30/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
07/18/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/17/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/19/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020583

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20583lbl.pdf

Therapeutic Equivalents for NDA 020583

LOTEMAX

SUSPENSION/DROPS;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%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	Yes	AB	020583	BAUSCH AND LOMB
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	215719	LUPIN LTD
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	207609	SENTISS
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	212450	SUN PHARM

Top