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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212430
Company: I3 PHARMS

Products on ANDA 212430

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFABUTIN	RIFABUTIN	150MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212430

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212430

RIFABUTIN

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MYCOBUTIN	RIFABUTIN	150MG	CAPSULE;ORAL	Prescription	Yes	AB	050689	PFIZER
RIFABUTIN	RIFABUTIN	150MG	CAPSULE;ORAL	Prescription	No	AB	212430	I3 PHARMS
RIFABUTIN	RIFABUTIN	150MG	CAPSULE;ORAL	Prescription	No	AB	215041	NOVITIUM PHARMA

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