Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076394
Company: PAR STERILE PRODUCTS

• Other Important Information from FDA

Products on ANDA 076394

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 076394

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2003	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/76394_Amiodarone Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/76394_Amiodarone Hydrochloride_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/076394_amiodarone-hydrochloride_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2006	SUPPL-8	Labeling		Label is not available on this site.
08/26/2005	SUPPL-7	Labeling		Label is not available on this site.
06/09/2005	SUPPL-6	Labeling		Label is not available on this site.

Labels for ANDA 076394

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/76394_Amiodarone Hydrochloride_Prntlbl.pdf