Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219265
Company: CARNEGIE

Products on ANDA 219265

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOMUSTINE	LOMUSTINE	10MG	CAPSULE;ORAL	Prescription	AB	No	No
LOMUSTINE	LOMUSTINE	40MG	CAPSULE;ORAL	Prescription	AB	No	No
LOMUSTINE	LOMUSTINE	100MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219265

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219265

LOMUSTINE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLEOSTINE	LOMUSTINE	10MG	CAPSULE;ORAL	Prescription	Yes	AB	017588	AZURITY
LOMUSTINE	LOMUSTINE	10MG	CAPSULE;ORAL	Prescription	No	AB	219265	CARNEGIE

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLEOSTINE	LOMUSTINE	40MG	CAPSULE;ORAL	Prescription	Yes	AB	017588	AZURITY
LOMUSTINE	LOMUSTINE	40MG	CAPSULE;ORAL	Prescription	No	AB	219265	CARNEGIE

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLEOSTINE	LOMUSTINE	100MG	CAPSULE;ORAL	Prescription	Yes	AB	017588	AZURITY
LOMUSTINE	LOMUSTINE	100MG	CAPSULE;ORAL	Prescription	No	AB	219265	CARNEGIE