Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079029
Company: ZYDUS PHARMS USA INC

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
09/16/2008 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2015 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/09/2015 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
03/09/2015 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/16/2013 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
05/31/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
05/31/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
08/31/2010 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
07/10/2009 SUPPL-1 Labeling

Label is not available on this site.

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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