Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213267
Company: NATCO

• REMS

Products on ANDA 213267

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THALIDOMIDE	THALIDOMIDE	150MG	CAPSULE;ORAL	Discontinued	None	No	No
THALIDOMIDE	THALIDOMIDE	50MG	CAPSULE;ORAL	Prescription	AB	No	No
THALIDOMIDE	THALIDOMIDE	100MG	CAPSULE;ORAL	Prescription	AB	No	No
THALIDOMIDE	THALIDOMIDE	200MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213267

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/24/2026	ORIG-2	Approval		STANDARD		Label is not available on this site.
04/27/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213267Orig1s000Panoramaltr.pdf

Therapeutic Equivalents for ANDA 213267

THALIDOMIDE

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THALIDOMIDE	THALIDOMIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	213267	NATCO
THALOMID	THALIDOMIDE	50MG	CAPSULE;ORAL	Prescription	Yes	AB	020785	BRISTOL-MYERS

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THALIDOMIDE	THALIDOMIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	213267	NATCO
THALOMID	THALIDOMIDE	100MG	CAPSULE;ORAL	Prescription	Yes	AB	020785	BRISTOL-MYERS

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THALIDOMIDE	THALIDOMIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	213267	NATCO
THALOMID	THALIDOMIDE	200MG	CAPSULE;ORAL	Prescription	Yes	AB	020785	BRISTOL-MYERS