Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076018
Company: BEDFORD

• Other Important Information from FDA

Products on ANDA 076018

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076018

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			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76018_Amiodarone%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76018_Amiodarone%20Hydrochloride_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076018_amiodarone-hydrochloride_toc.html

Labels for ANDA 076018

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76018_Amiodarone%20Hydrochloride_Prntlbl.pdf