Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219918
Company: NOVITIUM PHARMA

Products on ANDA 219918

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFAMPIN	RIFAMPIN	150MG	CAPSULE;ORAL	Prescription	AB	No	No
RIFAMPIN	RIFAMPIN	300MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219918

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219918

RIFAMPIN

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIFAMPIN	RIFAMPIN	150MG	CAPSULE;ORAL	Prescription	No	AB	065390	CHARTWELL MOLECULAR
RIFAMPIN	RIFAMPIN	150MG	CAPSULE;ORAL	Prescription	No	AB	064150	EPIC PHARMA LLC
RIFAMPIN	RIFAMPIN	150MG	CAPSULE;ORAL	Prescription	No	AB	090034	LUPIN PHARMS
RIFAMPIN	RIFAMPIN	150MG	CAPSULE;ORAL	Prescription	No	AB	219918	NOVITIUM PHARMA

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIFAMPIN	RIFAMPIN	300MG	CAPSULE;ORAL	Prescription	No	AB	065390	CHARTWELL MOLECULAR
RIFAMPIN	RIFAMPIN	300MG	CAPSULE;ORAL	Prescription	No	AB	064150	EPIC PHARMA LLC
RIFAMPIN	RIFAMPIN	300MG	CAPSULE;ORAL	Prescription	No	AB	090034	LUPIN PHARMS
RIFAMPIN	RIFAMPIN	300MG	CAPSULE;ORAL	Prescription	No	AB	219918	NOVITIUM PHARMA
RIMACTANE	RIFAMPIN	300MG	CAPSULE;ORAL	Prescription	No	AB	050429	OXFORD PHARMS