Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040506
Company: CHARTWELL RX

Products on ANDA 040506

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 040506

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2003	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
01/10/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/10/2009	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/15/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040506

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	CHARTWELL RX
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG/5ML	SYRUP;ORAL	Prescription	No	AA	040253	PHARM ASSOC
ZARONTIN	ETHOSUXIMIDE	250MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	080258	PARKE-DAVIS