Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022184
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LUMIGAN | BIMATOPROST | 0.01% | SOLUTION/DROPS;OPHTHALMIC | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
08/31/2010 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022184s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022184s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022184_lumigan_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022184Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/08/2022 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022184s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022184Orig1s009ltr.pdf | |
09/29/2020 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022184s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022184Orig1s008ltr.pdf | |
07/29/2017 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022184s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022184Orig1s006ltr.pdf | |
09/29/2014 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022184s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022184Orig1s005ltr.pdf | |
09/19/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/22/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/15/2012 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022184s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022184s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/08/2022 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022184s009lbl.pdf | |
09/29/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022184s008lbl.pdf | |
07/29/2017 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022184s006lbl.pdf | |
09/29/2014 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022184s005lbl.pdf | |
03/15/2012 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022184s001lbl.pdf | |
08/31/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022184s000lbl.pdf |