Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021275
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUMIGAN BIMATOPROST 0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/16/2001 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21275lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan0.03percentOpthalmisSolution_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2017 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021275s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021275Orig1s027ltr.pdf
09/29/2014 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021275s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021275Orig1s026ltr.pdf
02/28/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/15/2012 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021275s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021275Orig1s023ltr.pdf
03/11/2011 SUPPL-22 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s022lbl.pdf
11/10/2003 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scs014,slr015ltr.pdf
11/10/2003 SUPPL-14 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scs014,slr015ltr.pdf
06/22/2006 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021275s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021275s013LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021275_S013_LUMIGAN.pdf
08/25/2003 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scp010,slr012ltr.pdf
03/11/2011 SUPPL-11 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s011lbl.pdf
08/25/2003 SUPPL-10 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scp010,slr012ltr.pdf
08/26/2002 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21275s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21275slr006ltr.pdf
04/12/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/2001 SUPPL-2 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-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021275s027lbl.pdf
09/29/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021275s026lbl.pdf
03/15/2012 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021275s023lbl.pdf
03/11/2011 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s022lbl.pdf
03/11/2011 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s011lbl.pdf
06/22/2006 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021275s013lbl.pdf
11/10/2003 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf
11/10/2003 SUPPL-14 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf
08/25/2003 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf
08/25/2003 SUPPL-10 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf
08/26/2002 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21275s6lbl.pdf
03/16/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21275lbl.pdf

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