Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074534
Company: HOSPIRA

Products on ANDA 074534

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074534

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
08/22/2024	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
01/26/2024	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 074534

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	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