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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076719
Company: COREPHARMA

Products on ANDA 076719

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	AB	No	No
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076719

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2007	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
04/02/2018	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/25/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
08/26/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/26/2013	SUPPL-8	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/22/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076719

AMLODIPINE BESYLATE

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	202553	ACCORD HLTHCARE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	078925	ALKEM
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	078021	AUROBINDO PHARMA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	076692	CHARTWELL RX
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	090752	CHINA RESOURCES
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	077073	CIPLA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	076719	COREPHARMA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	078552	EPIC PHARMA LLC
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	077955	INVAGEN PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	206367	INVAGEN PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	078043	LUPIN
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	078453	ORBION PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	078414	OXFORD PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	207821	POLYGEN PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	077516	STRIDES PHARMA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	076846	TEVA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	203245	UNICHEM
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	078226	ZYDUS PHARMS USA
NORVASC	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	019787	VIATRIS

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	202553	ACCORD HLTHCARE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078925	ALKEM
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078021	AUROBINDO PHARMA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	076692	CHARTWELL RX
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	090752	CHINA RESOURCES
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	077073	CIPLA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	076719	COREPHARMA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078552	EPIC PHARMA LLC
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	077955	INVAGEN PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	206367	INVAGEN PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078043	LUPIN
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078453	ORBION PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078414	OXFORD PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	207821	POLYGEN PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	077516	STRIDES PHARMA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	076846	TEVA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	203245	UNICHEM
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078226	ZYDUS PHARMS USA
NORVASC	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Prescription	Yes	AB	019787	VIATRIS

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202553	ACCORD HLTHCARE
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078925	ALKEM
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078021	AUROBINDO PHARMA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	076692	CHARTWELL RX
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	090752	CHINA RESOURCES
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077073	CIPLA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	076719	COREPHARMA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078552	EPIC PHARMA LLC
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077955	INVAGEN PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	206367	INVAGEN PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078043	LUPIN
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078453	ORBION PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078414	OXFORD PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	207821	POLYGEN PHARMS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077516	STRIDES PHARMA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	076846	TEVA
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203245	UNICHEM
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078226	ZYDUS PHARMS USA
NORVASC	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	019787	VIATRIS

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