Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210762
Company: FRESENIUS KABI USA

Products on ANDA 210762

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 210762

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210762Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210762

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