Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201923
Company: ALIMERA SCIENCES INC
Company: ALIMERA SCIENCES INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ILUVIEN | FLUOCINOLONE ACETONIDE | 0.19MG | IMPLANT;INTRAVITREAL | 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 |
---|---|---|---|---|---|---|---|
09/26/2014 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201923s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201923Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/201923Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/08/2017 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201923s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201923Orig1s002ltr.pdf | |
05/18/2015 | SUPPL-1 | 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 |
---|---|---|---|---|---|
03/08/2017 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201923s002lbl.pdf | |
09/26/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201923s000lbl.pdf |