Drugs@FDA: FDA-Approved Drugs

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

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

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 207609 HI TECH

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