Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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 212080 AKORN

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English