Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016619
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUBLIMAZE PRESERVATIVE FREE FENTANYL 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
02/19/1968 ORIG-1 Approval Type 3 - New Dosage Form 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
01/24/2019 SUPPL-39 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016619Orig1s039ltr.pdf
12/16/2016 SUPPL-38 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016619s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016619Orig1s038ltr.pdf
05/18/2016 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

07/03/2013 SUPPL-34 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016619s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016619Orig1s034ltr.pdf
10/17/2003 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16619slr032ltr.pdf
04/26/1996 SUPPL-31 Labeling

Label is not available on this site.

02/22/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/23/1993 SUPPL-29 Labeling

Label is not available on this site.

12/23/1993 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/23/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/23/1993 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1992 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/07/1992 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1990 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/25/1991 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1987 SUPPL-20 Labeling

Label is not available on this site.

09/05/1986 SUPPL-19 Labeling

Label is not available on this site.

09/05/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/1985 SUPPL-17 Labeling

Label is not available on this site.

09/07/1983 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/07/1982 SUPPL-12 Labeling

Label is not available on this site.

07/07/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1981 SUPPL-10 Labeling

Label is not available on this site.

02/24/1981 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1980 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1976 SUPPL-4 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2016 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016619s038lbl.pdf
12/16/2016 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016619s038lbl.pdf
07/03/2013 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016619s034lbl.pdf

SUBLIMAZE 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
FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 019115 HOSPIRA
FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 072786 HOSPIRA
FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019101 WEST-WARD PHARMS INT
SUBLIMAZE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 016619 AKORN

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