Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125422
Company: THROMBOGENICS, INC
Company: THROMBOGENICS, INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
JETREA | OCRIPLASMIN | 2.5MG/ML | INJECTABLE; INTRAVITREAL | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
10/17/2012 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125422s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125422Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125422_jetrea_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/22/2017 | SUPPL-38 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125422s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125422Orig1s038ltr.pdf | |
03/27/2016 | SUPPL-37 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125422s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125422Orig1s037ltr.pdf | |
06/13/2014 | SUPPL-25 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125422s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125422Orig1s025ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/22/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125422s038lbl.pdf | |
03/27/2016 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125422s037lbl.pdf | |
06/13/2014 | SUPPL-25 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125422s025lbl.pdf | |
10/17/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125422s000lbl.pdf |