Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019115
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL CITRATE FENTANYL 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
01/12/1985 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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-31 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019115s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019115Orig1s030,s031ltr.pdf
12/16/2016 SUPPL-30 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019115s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019115Orig1s030,s031ltr.pdf
12/16/2016 SUPPL-21 Labeling

Label is not available on this site.

07/19/2005 SUPPL-18 Labeling

Label is not available on this site.

10/25/2002 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/07/2002 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/04/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/30/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/30/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/08/1992 SUPPL-9 Labeling

Label is not available on this site.

07/18/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/18/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/09/1990 SUPPL-6 Labeling

Label is not available on this site.

03/10/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/17/1989 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-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019115s030s031lbl.pdf
12/16/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019115s030s031lbl.pdf
12/16/2016 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019115s030s031lbl.pdf
12/16/2016 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019115s030s031lbl.pdf

FENTANYL 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
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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