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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072786
Company: HOSPIRA

Products on ANDA 072786

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENTANYL CITRATE PRESERVATIVE FREE	FENTANYL CITRATE	EQ 0.05MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072786

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/1991	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
01/22/2024	SUPPL-42	Labeling-Package Insert		Label is not available on this site.
01/19/2024	SUPPL-40	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/11/2020	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
06/11/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
06/11/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/14/2001	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/22/1995	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/16/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072786

FENTANYL CITRATE 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	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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