Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075135
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PACERONE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription AB No No
PACERONE 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
04/30/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2019 SUPPL-54 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/01/2019 SUPPL-52 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/01/2019 SUPPL-51 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

11/01/2019 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-48 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-47 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-46 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

06/17/2013 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

06/17/2013 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

11/30/2010 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

12/01/2009 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

04/28/2009 SUPPL-39 Labeling

Label is not available on this site.

11/01/2019 SUPPL-35 Labeling

Label is not available on this site.

11/16/2007 SUPPL-34 Labeling

Label is not available on this site.

11/01/2019 SUPPL-27 Labeling

Label is not available on this site.

11/01/2019 SUPPL-26 Labeling

Label is not available on this site.

04/04/2006 SUPPL-25 Labeling

Label is not available on this site.

02/13/2006 SUPPL-18 Labeling

Label is not available on this site.

10/04/2004 SUPPL-17 Labeling

Label is not available on this site.

01/05/2004 SUPPL-16 Labeling

Label is not available on this site.

09/24/2003 SUPPL-13 Labeling

Label is not available on this site.

04/12/2005 SUPPL-11 Labeling

Label is not available on this site.

12/19/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/2002 SUPPL-8 Labeling

Label is not available on this site.

04/12/2000 SUPPL-7 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf
04/12/2000 SUPPL-6 Manufacturing (CMC)-Manufacturing Process Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf
04/12/2000 SUPPL-5 Manufacturing (CMC)-Facility Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf
02/01/2000 SUPPL-4 Bioequivalence Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf
09/24/1999 SUPPL-3 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf
12/02/1999 SUPPL-2 Manufacturing (CMC)-Facility Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf
12/02/1999 SUPPL-1 Manufacturing (CMC) Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf

PACERONE

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 075315 SANDOZ
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 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 075389 MAYNE PHARMA INC
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
PACERONE AMIODARONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 075135 UPSHER SMITH LABS

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