Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077069
Company: MURTY 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
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG 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
04/08/2005 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
05/19/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/19/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/19/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/31/2013 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/11/2007 SUPPL-2 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

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 077069 MURTY PHARMS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 075315 SANDOZ
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 076362 TARO PHARM

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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