Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019353
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALFENTA ALFENTANIL HYDROCHLORIDE EQ 0.5MG 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
12/29/1986 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2016 SUPPL-21 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019353s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019353Orig1s021ltr.pdf
07/24/2015 SUPPL-19 Labeling-Patient Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019353Orig1s019ltr.pdf
05/25/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/20/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/30/1995 SUPPL-13 Labeling

Label is not available on this site.

02/22/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/03/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/18/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1993 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

11/10/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/07/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/07/1994 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/1991 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1990 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1988 SUPPL-1 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-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019353s021lbl.pdf
12/16/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019353s021lbl.pdf
07/24/2015 SUPPL-19 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf
07/24/2015 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf

ALFENTA

INJECTABLE;INJECTION; EQ 0.5MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALFENTA ALFENTANIL HYDROCHLORIDE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019353 AKORN
ALFENTANIL ALFENTANIL HYDROCHLORIDE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075221 HOSPIRA

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