Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040686
Company: EPIC PHARMA LLC

Products on ANDA 040686

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040686

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2008	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
11/10/2022	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/18/2021	SUPPL-12	Labeling-Patient Package Insert		Label is not available on this site.
03/17/2020	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
01/14/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/10/2009	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040686

ETHOSUXIMIDE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	040430	BIONPHARMA
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	040686	EPIC PHARMA LLC
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	200892	HERITAGE PHARMS INC
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	210654	PURACAP PHARM LLC
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	211928	STRIDES PHARMA
ZARONTIN	ETHOSUXIMIDE	250MG	CAPSULE;ORAL	Prescription	Yes	AB	012380	PARKE DAVIS