Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019050
Company: AKORN
Company: AKORN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUFENTA PRESERVATIVE FREE | SUFENTANIL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/07/2019 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019050s037lbl.pdf | |
12/16/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019050s034lbl.pdf | |
12/16/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019050s034lbl.pdf | |
03/20/2014 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf | |
03/20/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf | |
06/04/2007 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019050s031lbl.pdf |