An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210245
Company: MSN

Products on ANDA 210245

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 210245

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2025	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210245Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 210245

POMALIDOMIDE

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	219718	CIPLA
POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	No	AB	213234	DR REDDYS
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	210245	MSN
POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	No	AB	220741	SANDOZ
POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE;ORAL	Prescription	No	AB	210232	SPIL
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	219718	CIPLA
POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	No	AB	213234	DR REDDYS
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	210245	MSN
POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	No	AB	220741	SANDOZ
POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE;ORAL	Prescription	No	AB	210232	SPIL
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	219718	CIPLA
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	No	AB	213234	DR REDDYS
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	210245	MSN
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	No	AB	220741	SANDOZ
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	No	AB	210232	SPIL
POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	No	AB	209956	TEVA PHARMS USA
POMALYST	POMALIDOMIDE	4MG	CAPSULE;ORAL	Prescription	Yes	AB	204026	BRISTOL

Top