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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019353
Company: RISING

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALFENTA ALFENTANIL HYDROCHLORIDE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/15/2023 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019353s029lbl.pdf
10/07/2019 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019353s023lbl.pdf
12/16/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019353s021lbl.pdf
12/16/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019353s021lbl.pdf
07/24/2015 SUPPL-19 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf
07/24/2015 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf
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