Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211182
Company: HETERO LABS LTD V

Products on ANDA 211182

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBRUTINIB	IBRUTINIB	140MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211182

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211182Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 211182

IBRUTINIB

CAPSULE;ORAL; 140MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBRUTINIB	IBRUTINIB	140MG	CAPSULE;ORAL	Prescription	No	AB	211182	HETERO LABS LTD V
IMBRUVICA	IBRUTINIB	140MG	CAPSULE;ORAL	Prescription	Yes	AB	205552	PHARMACYCLICS LLC