Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064150
Company: EPIC PHARMA LLC

Products on ANDA 064150

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1997	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064150aplet.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064150review.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2023	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
01/14/2022	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
09/13/2021	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
08/17/2020	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
08/17/2020	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
08/17/2020	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
08/17/2020	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/17/2020	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
08/17/2020	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
07/19/2013	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
06/13/2011	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/06/2005	SUPPL-11	Labeling		Label is not available on this site.
06/28/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/09/2000	SUPPL-6	Labeling		Label is not available on this site.
02/02/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
03/03/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/19/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/02/1998	SUPPL-2	Labeling		Label is not available on this site.
01/02/1998	SUPPL-1	Manufacturing (CMC)-New Strength		Label is not available on this site.

Therapeutic Equivalents for ANDA 064150

RIFAMPIN

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

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