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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074534
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUFENTANIL CITRATE SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
12/11/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/25/2021 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

06/25/2021 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

01/26/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

10/25/2002 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/06/2002 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/13/1998 SUPPL-1 Labeling

Label is not available on this site.

SUFENTANIL CITRATE

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 AKORN
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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