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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075761
Company: FRESENIUS KABI USA

Other Important Information from FDA

Products on ANDA 075761

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075761

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2002	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75761.TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075761_s000_AmiodaroneTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/04/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
10/22/2007	SUPPL-12	Labeling		Label is not available on this site.
10/21/2005	SUPPL-8	Labeling		Label is not available on this site.
10/20/2004	SUPPL-6	Labeling		Label is not available on this site.
11/24/2003	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075761

AMIODARONE HYDROCHLORIDE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077610	ACELLA
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077834	ACELLA
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075761	FRESENIUS KABI USA
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077161	GLAND PHARMA LTD
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077234	HIKMA FARMACEUTICA
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	203884	HOSPIRA
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076217	MYLAN INSTITUTIONAL

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