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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065421
Company: MYLAN LABS LTD

Products on ANDA 065421

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFAMPIN	RIFAMPIN	600MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065421

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2008	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2025	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
02/15/2024	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
02/15/2024	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
02/15/2024	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
02/15/2024	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
02/15/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
07/01/2020	SUPPL-14	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/01/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/01/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/27/2015	SUPPL-3	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065421

RIFAMPIN

INJECTABLE;INJECTION; 600MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIFADIN	RIFAMPIN	600MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050627	SANOFI AVENTIS US
RIFAMPIN	RIFAMPIN	600MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065502	EPIC PHARMA LLC
RIFAMPIN	RIFAMPIN	600MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091181	FRESENIUS KABI USA
RIFAMPIN	RIFAMPIN	600MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	064217	HIKMA
RIFAMPIN	RIFAMPIN	600MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205039	HIKMA PHARMS
RIFAMPIN	RIFAMPIN	600MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065421	MYLAN LABS LTD

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