Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211119
Company: AJANTA PHARMA LTD

Products on ANDA 211119

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	AB	No	No
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211119

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211119

CHOLESTYRAMINE

POWDER;ORAL; EQ 4GM RESIN/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	211119	AJANTA PHARMA LTD
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	211856	ALKEM LABS LTD
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	074557	EPIC PHARMA LLC
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	077204	PAR PHARM
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	209597	TAGI
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	211799	ALKEM LABS LTD
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	074558	EPIC PHARMA LLC
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	077203	PAR PHARM
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	209599	TAGI
LOCHOLEST	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	074561	CHARTWELL RX
LOCHOLEST LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	074562	CHARTWELL RX
PREVALITE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER;ORAL	Prescription	No	AB	073263	UPSHER SMITH LABS

POWDER;ORAL; EQ 4GM RESIN/SCOOPFUL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	211119	AJANTA PHARMA LTD
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	211856	ALKEM LABS LTD
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	074557	EPIC PHARMA LLC
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	077204	PAR PHARM
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	209597	TAGI
CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	202901	ZYDUS PHARMS
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	211799	ALKEM LABS LTD
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	074558	EPIC PHARMA LLC
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	077203	PAR PHARM
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	209599	TAGI
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	202902	ZYDUS PHARMS
LOCHOLEST	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	074561	CHARTWELL RX
LOCHOLEST LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	074562	CHARTWELL RX
PREVALITE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER;ORAL	Prescription	No	AB	073263	UPSHER SMITH LABS