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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075389
Company: DR REDDYS LABS SA

Other Important Information from FDA

Products on ANDA 075389

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
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075389

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75389ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/21/2008	SUPPL-8	Labeling		Label is not available on this site.
04/12/2007	SUPPL-7	Labeling		Label is not available on this site.
03/07/2007	SUPPL-6	Labeling		Label is not available on this site.
05/03/2005	SUPPL-4	Labeling		Label is not available on this site.
08/28/2002	SUPPL-3	Labeling		Label is not available on this site.
08/23/2002	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 075389

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	077069	CHARTWELL RX
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	No	AB	075389	DR REDDYS LABS SA
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	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	CHARTWELL RX
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075389	DR REDDYS LABS SA
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	078578	RUBICON
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075424	TARO
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	079029	ZYDUS PHARMS USA INC
PACERONE	AMIODARONE HYDROCHLORIDE	100MG	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	CHARTWELL RX
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	No	AB	075389	DR REDDYS LABS SA
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	079029	ZYDUS PHARMS USA INC
PACERONE	AMIODARONE HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	No	AB	075135	UPSHER SMITH LABS

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