Drugs@FDA: FDA Approved Drug Products

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

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

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