Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074413
Company: HIKMA

Products on ANDA 074413

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 074413

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/1995	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
01/22/2024	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
01/22/2024	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
01/19/2024	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
04/22/2004	SUPPL-15	Labeling		Label is not available on this site.
03/27/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
04/10/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/10/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/07/1998	SUPPL-9	Labeling		Label is not available on this site.
01/31/1997	SUPPL-8	Labeling		Label is not available on this site.
05/02/1997	SUPPL-7	Labeling		Label is not available on this site.
05/02/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/02/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/02/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/06/1996	SUPPL-3	Labeling		Label is not available on this site.
05/01/1996	SUPPL-2	Labeling		Label is not available on this site.
07/17/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074413

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