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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217042
Company: MACLEODS PHARMS

Products on ANDA 217042

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217042

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217042

RIFAPENTINE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PRIFTIN	RIFAPENTINE	150MG	TABLET;ORAL	Prescription	Yes	AB	021024	SANOFI AVENTIS US
RIFAPENTINE	RIFAPENTINE	150MG	TABLET;ORAL	Prescription	No	AB	217042	MACLEODS PHARMS

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