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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019115
Company: HOSPIRA

Products on NDA 019115

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019115

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
12/15/2023	SUPPL-42	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019115s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019115Orig1s042ltr.pdf
10/07/2019	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019115s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019115Orig1s033ltr.pdf
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.

Labels for NDA 019115

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019115s042lbl.pdf
10/07/2019	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019115s033lbl.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-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

Therapeutic Equivalents for NDA 019115

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	212086	FRESENIUS KABI USA
FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.05MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019101	HIKMA
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	210762	FRESENIUS KABI USA
FENTANYL CITRATE PRESERVATIVE FREE	FENTANYL CITRATE	EQ 0.05MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	072786	HOSPIRA
SUBLIMAZE PRESERVATIVE FREE	FENTANYL CITRATE	EQ 0.05MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016619	RISING

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