Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040253
Company: PHARM ASSOC

Products on ANDA 040253

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG/5ML	SYRUP;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040253

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40253_Ethosuximide_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40253ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040253_ethosuximide_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/15/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/04/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 040253

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40253_Ethosuximide_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040253

ETHOSUXIMIDE

SYRUP;ORAL; 250MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG/5ML	SYRUP;ORAL	Prescription	No	AA	040506	MIKART
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG/5ML	SYRUP;ORAL	Prescription	No	AA	040253	PHARM ASSOC
ZARONTIN	ETHOSUXIMIDE	250MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	080258	PARKE-DAVIS