Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074413
Company: WEST-WARD PHARMS INT
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
12/15/1995 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
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.

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 074534 HOSPIRA
SUFENTANIL CITRATE SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074413 WEST-WARD PHARMS INT

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