Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022369
Company: ABBVIE
Company: ABBVIE
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 |
---|---|---|---|---|---|
08/26/2021 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022369s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022369Orig1s014ltr.pdf | |
09/29/2020 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022369s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022369Orig1s012ltr.pdf | |
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 |
---|---|---|---|---|---|
08/26/2021 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022369s014lbl.pdf | |
09/29/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022369s012lbl.pdf | |
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 |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;TOPICAL | Prescription | No | AT | 201894 | APOTEX |
BIMATOPROST | BIMATOPROST | 0.03% | SOLUTION/DROPS;TOPICAL | Prescription | No | AT | 202719 | SANDOZ |
LATISSE | BIMATOPROST | 0.03% | SOLUTION/DROPS;TOPICAL | Prescription | Yes | AT | 022369 | ABBVIE |