Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074739
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription AB 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
11/30/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-739_Amiodarone_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74739ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-739_Amiodarone.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2015 SUPPL-34 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/06/2015 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/06/2015 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/31/2013 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/22/2011 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

01/08/2010 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

07/22/2009 SUPPL-25 Labeling

Label is not available on this site.

01/16/2009 SUPPL-24 Labeling

Label is not available on this site.

07/14/2008 SUPPL-23 Labeling

Label is not available on this site.

03/12/2008 SUPPL-22 Labeling

Label is not available on this site.

08/30/2007 SUPPL-21 Labeling

Label is not available on this site.

04/30/2007 SUPPL-20 Labeling

Label is not available on this site.

08/07/2006 SUPPL-19 Labeling

Label is not available on this site.

04/04/2006 SUPPL-18 Labeling

Label is not available on this site.

05/11/2005 SUPPL-15 Labeling

Label is not available on this site.

05/24/2002 SUPPL-13 Labeling

Label is not available on this site.

04/11/2001 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

02/29/2000 SUPPL-7 Labeling

Label is not available on this site.

10/26/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/02/1999 SUPPL-3 Labeling

Label is not available on this site.

09/02/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/02/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-739_Amiodarone_prntlbl.pdf

AMIODARONE HYDROCHLORIDE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 078578 APOTEX INC
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 204742 AUROBINDO PHARMA LTD
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 075389 MAYNE PHARMA INC
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 077069 MURTY PHARMS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 075315 SANDOZ
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 075424 TARO PHARM
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 074739 TEVA PHARMS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 079029 ZYDUS PHARMS USA INC
PACERONE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 075135 UPSHER-SMITH LABS

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