Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075188
Company: MYLAN

• Other Important Information from FDA

Products on ANDA 075188

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075188

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2008	SUPPL-7	Labeling		Label is not available on this site.
05/05/2005	SUPPL-6	Labeling		Label is not available on this site.
08/06/2004	SUPPL-5	Labeling		Label is not available on this site.
05/20/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/18/2000	SUPPL-3	Labeling		Label is not available on this site.
07/21/1999	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 075188

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_prntlbl.pdf