Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022369
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LATISSE BIMATOPROST 0.03% SOLUTION/DROPS;TOPICAL Prescription AT 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
12/24/2008 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022369lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022369s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022369_latisse_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022369s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2017 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022369s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022369Orig1s011ltr.pdf
09/04/2014 SUPPL-10 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022369Orig1s008,s010ltr.pdf
11/01/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/04/2014 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022369Orig1s008s,010ltr.pdf
03/13/2013 SUPPL-7 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022369s007lbl.pdf
01/31/2013 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/29/2012 SUPPL-5 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022369s005lbl.pdf
09/07/2011 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022369s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022369s004ltr.pdf
09/07/2011 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/29/2017 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022369s011lbl.pdf
09/04/2014 SUPPL-10 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf
09/04/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf
03/13/2013 SUPPL-7 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022369s007lbl.pdf
03/29/2012 SUPPL-5 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022369s005lbl.pdf
09/07/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022369s004lbl.pdf
12/24/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022369lbl.pdf

LATISSE

SOLUTION/DROPS;TOPICAL; 0.03%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BIMATOPROST BIMATOPROST 0.03% SOLUTION/DROPS;TOPICAL Prescription No AT 210515 ALEMBIC PHARMS LTD
BIMATOPROST BIMATOPROST 0.03% SOLUTION/DROPS;TOPICAL Prescription No AT 201894 APOTEX INC
BIMATOPROST BIMATOPROST 0.03% SOLUTION/DROPS;TOPICAL Prescription No AT 203051 HI TECH
BIMATOPROST BIMATOPROST 0.03% SOLUTION/DROPS;TOPICAL Prescription No AT 202719 SANDOZ INC
LATISSE BIMATOPROST 0.03% SOLUTION/DROPS;TOPICAL Prescription Yes AT 022369 ALLERGAN

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