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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210164
Company: APOTEX

Products on ANDA 210164

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE;ORAL	Prescription	AB	No	No
POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	AB	No	No
POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	AB	No	No
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210164

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/11/2024	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
02/26/2025	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 210164

POMALIDOMIDE

CAPSULE;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE;ORAL	Prescription	No	AB	210164	APOTEX
POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE;ORAL	Prescription	No	AB	210111	BRECKENRIDGE
POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE;ORAL	Prescription	No	AB	210249	EUGIA PHARMA
POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE;ORAL	Prescription	No	AB	210236	HETERO LABS LTD V
POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE;ORAL	Prescription	No	AB	209956	TEVA PHARMS USA
POMALYST	POMALIDOMIDE	1MG	CAPSULE;ORAL	Prescription	Yes	AB	204026	BRISTOL

CAPSULE;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	No	AB	210164	APOTEX
POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	No	AB	210111	BRECKENRIDGE
POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	No	AB	210249	EUGIA PHARMA
POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	No	AB	210236	HETERO LABS LTD V
POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	No	AB	209956	TEVA PHARMS USA
POMALYST	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	Yes	AB	204026	BRISTOL

CAPSULE;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	No	AB	210164	APOTEX
POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	No	AB	210111	BRECKENRIDGE
POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	No	AB	210249	EUGIA PHARMA
POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	No	AB	210236	HETERO LABS LTD V
POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	No	AB	209956	TEVA PHARMS USA
POMALYST	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	Yes	AB	204026	BRISTOL

CAPSULE;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	No	AB	210164	APOTEX
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	No	AB	210111	BRECKENRIDGE
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	No	AB	210249	EUGIA PHARMA
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	No	AB	210236	HETERO LABS LTD V
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	No	AB	209956	TEVA PHARMS USA
POMALYST	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	Yes	AB	204026	BRISTOL

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