Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065390
Company: CHARTWELL MOLECULAR

Products on ANDA 065390

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 065390

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2008	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
08/16/2023	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
07/21/2022	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
01/19/2022	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
09/13/2021	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
09/02/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/14/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/27/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/15/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065390

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