Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075424
Company: TARO PHARM
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
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG 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
03/30/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75424ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/05/2015 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/05/2015 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/31/2013 SUPPL-17 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/31/2013 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/04/2010 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/02/2009 SUPPL-13 Labeling

Label is not available on this site.

12/05/2008 SUPPL-12 Labeling

Label is not available on this site.

06/07/2005 SUPPL-8 Labeling

Label is not available on this site.

12/09/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/18/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/09/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/18/2002 SUPPL-2 Labeling

Label is not available on this site.

12/18/2002 SUPPL-1 Manufacturing (CMC)-New Strength

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

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 077069 MURTY PHARMS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 075424 TARO PHARM
PACERONE AMIODARONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 075135 UPSHER-SMITH LABS

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