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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019050
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf
03/20/2014 SUPPL-32 Labeling-Container/Carton Labels 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
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