Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020377
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORDARONE AMIODARONE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
08/03/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/28/2006 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020377s020ltr.pdf
03/13/2009 SUPPL-19 Labeling

Label is not available on this site.

09/15/2005 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020377s018ltr.pdf
11/02/2004 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s017ltr.pdf
09/02/2004 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s016ltr.pdf
11/04/2004 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s007,008,015ltr.pdf
05/06/2003 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr014ltr.pdf
05/06/2003 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr013ltr.pdf
05/09/2003 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr010,012ltr.pdf
03/13/2009 SUPPL-11 Efficacy-New Patient Population

Label is not available on this site.

05/09/2003 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20377slr010,012ltr.pdf
04/11/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/04/2004 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s007,008,015ltr.pdf
11/04/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20377s007,008,015ltr.pdf
05/02/2001 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/11/2001 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20377s4s5ltr.pdf
07/11/2001 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20377s4s5ltr.pdf
05/14/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/10/1997 SUPPL-2 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020377-S2_Cordarone_toc.cfm
10/18/1995 SUPPL-1 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020377-S1_Cordarone_toc.cfm

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