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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019050
Company: RISING

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/04/1984 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2025 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019050s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019050Orig1s045ltr.pdf
12/15/2023 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019050s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019050Orig1s043ltr.pdf
10/07/2019 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019050s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019050Orig1s037ltr.pdf
12/16/2016 SUPPL-34 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019050s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019050Orig1s034ltr.pdf
03/20/2014 SUPPL-32 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019050Orig1s032ltr.pdf
06/04/2007 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019050s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019050s031ltr.pdf
05/25/1999 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
05/26/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
05/01/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
08/27/2001 SUPPL-25 Labeling

Label is not available on this site.
06/21/1996 SUPPL-24 Labeling

Label is not available on this site.
08/12/1997 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
02/22/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
11/10/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
03/23/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
03/23/1994 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/23/1994 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
03/19/1993 SUPPL-17 Efficacy-New Route Of Administration

Label is not available on this site.
10/05/1990 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
04/29/1987 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
11/14/1986 SUPPL-10 Labeling

Label is not available on this site.
11/14/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
08/06/1986 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
03/18/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
03/18/1986 SUPPL-6 Labeling

Label is not available on this site.
06/20/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
08/21/1985 SUPPL-3 Labeling

Label is not available on this site.
08/21/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
09/10/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/22/2025 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019050s045lbl.pdf
12/15/2023 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019050s043lbl.pdf
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

SUFENTA PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 0.05MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SUFENTA PRESERVATIVE FREE SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019050 RISING
SUFENTANIL CITRATE SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074413 HIKMA
SUFENTANIL CITRATE SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074534 HOSPIRA
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