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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071814
Company: EPIC PHARMA LLC

Products on ANDA 071814

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071814

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/1988	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
01/17/2023	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
02/05/2021	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
04/20/2015	SUPPL-13	Labeling		Label is not available on this site.
11/01/2002	SUPPL-9	Labeling		Label is not available on this site.
11/06/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
08/08/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/27/2001	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/09/1998	SUPPL-5	Labeling		Label is not available on this site.
03/28/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/14/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/14/1993	SUPPL-2	Labeling		Label is not available on this site.
05/12/1989	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071814

OXAZEPAM

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	072253	ACTAVIS ELIZABETH
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	071814	EPIC PHARMA LLC
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	071026	UNITED RES LABS

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