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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090034
Company: LUPIN PHARMS

Products on ANDA 090034

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090034

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/2013	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
08/16/2023	SUPPL-22	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/30/2023	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
08/30/2022	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
08/30/2022	SUPPL-17	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/14/2021	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/17/2020	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/31/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/31/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/31/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/31/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/31/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090034

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

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
RIMACTANE	RIFAMPIN	300MG	CAPSULE;ORAL	Prescription	No	AB	050429	OXFORD PHARMS

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