Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040430
Company: BIONPHARMA

Products on ANDA 040430

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 040430

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2002	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
02/16/2022	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/01/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
01/07/2014	SUPPL-8	Labeling-Medication Guide		Label is not available on this site.
10/19/2012	SUPPL-7	REMS-Modified		Label is not available on this site.
12/27/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/10/2009	SUPPL-5	Labeling		Label is not available on this site.
03/03/2008	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040430

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	211928	ONESOURCE SPECIALTY
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	210654	PURACAP PHARM LLC
ZARONTIN	ETHOSUXIMIDE	250MG	CAPSULE;ORAL	Prescription	Yes	AB	012380	PARKE DAVIS