Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075315
Company: UPSHER SMITH LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription AB No Yes
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG 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
12/23/1998 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75315ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075315_amiodarone_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2019 SUPPL-47 Labeling-Package Insert

Label is not available on this site.
11/21/2019 SUPPL-46 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/21/2019 SUPPL-45 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/24/2015 SUPPL-44 Labeling-Package Insert

Label is not available on this site.
07/24/2015 SUPPL-42 Labeling-Package Insert

Label is not available on this site.
07/24/2015 SUPPL-41 Labeling-Package Insert

Label is not available on this site.
07/24/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
07/24/2015 SUPPL-36 Labeling-Package Insert

Label is not available on this site.
06/28/2013 SUPPL-29 Labeling-Package Insert

Label is not available on this site.
05/31/2013 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
05/31/2013 SUPPL-27 Labeling-Package Insert

Label is not available on this site.
06/29/2010 SUPPL-26 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/17/2008 SUPPL-25 Labeling

Label is not available on this site.
11/30/2006 SUPPL-22 Labeling

Label is not available on this site.
04/10/2006 SUPPL-21 Labeling

Label is not available on this site.
03/28/2006 SUPPL-20 Labeling

Label is not available on this site.
03/28/2006 SUPPL-18 Labeling

Label is not available on this site.
02/18/2005 SUPPL-17 Labeling

Label is not available on this site.
10/29/2004 SUPPL-16 Labeling

Label is not available on this site.
10/04/2004 SUPPL-15 Labeling

Label is not available on this site.
06/24/2004 SUPPL-12 Labeling

Label is not available on this site.
08/26/2002 SUPPL-9 Labeling

Label is not available on this site.
05/08/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
05/08/2002 SUPPL-7 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s005,006,007ltr.pdf
01/11/2000 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s005,006,007ltr.pdf
06/30/2000 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75315S4,5ltr.pdf
06/30/2000 SUPPL-4 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75315S4,5ltr.pdf
02/02/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.
07/21/1999 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 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 078578 RUBICON
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 075424 TARO
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 074739 TEVA PHARMS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 213446 UNICHEM
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 075315 UPSHER SMITH LABS
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; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 075389 MAYNE PHARMA INC
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 077069 MURTY PHARMS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 078578 RUBICON
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 076362 TARO
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 075315 UPSHER SMITH LABS
PACERONE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 075135 UPSHER SMITH LABS

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