Ethosuximide Oral Capsule

Brand(s)
Zarontin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Parke-Davis Div Of Pfizer Inc (2014-07-09)
Oldest Current Product
2000-09-22
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\ETHOSUXIMIDE
FDAOB
ORAL\CAPSULE\ETHOSUXIMIDE
SPL Active
ORAL\CAPSULE, LIQUID FILLED\ETHOSUXIMIDE
ORAL\CAPSULE\ETHOSUXIMIDE
SPL Moiety
ORAL\CAPSULE, LIQUID FILLED\ETHOSUXIMIDE
ORAL\CAPSULE\ETHOSUXIMIDE

product(s) by strength(s)

ethosuximide 250 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000710237ZarontinNDAParke-Davis Div Of Pfizer Inc2000-09-22ETHOSUXIMIDEORALCAPSULENDA0123800e008f33-70a1-4bc6-b3a0-d45214418ab6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550532ANDAHeritage Pharmaceuticals Inc.2012-10-10ETHOSUXIMIDEORALCAPSULEANDA2008920d0965f7-d780-4d1c-8ecf-77387483cc02
2501110901ANDAPliva Inc.2002-11-01ETHOSUXIMIDEORALCAPSULEANDA0404309d2075a7-8b88-42d5-8df5-05e4ca72f4b2
3597622250NDA AUTHORIZED GENERICGreenstone Llc2000-09-22ETHOSUXIMIDEORALCAPSULENDA0123804b61118d-1046-4510-b327-0f8d41acd156
4617480025ANDAVersapharm Incorporated2008-09-01ETHOSUXIMIDEORALCAPSULEANDA04068601e8e8ee-b19f-4b3f-a140-9c7391393e1c
5683820443ANDAZydus Pharmaceuticals (Usa) Inc.2012-10-10ETHOSUXIMIDEORALCAPSULEANDA200892cb5577e2-e906-438f-b13d-e55709a0e7fd
6693870108ANDABanner Life Sciences Llc.2015-06-01ETHOSUXIMIDEORALCAPSULE, LIQUID FILLEDANDA040430bfb2be16-9fe1-48bd-b054-25e2b1ed7a20

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA040430ETHOSUXIMIDEBANNER LIFE SCIENCES LLC2002-10-28ANDA040430_001
2ANDA040686ETHOSUXIMIDEVERSAPHARM INC2008-05-28ANDA040686_001
3ANDA200892ETHOSUXIMIDEHERITAGE PHARMACEUTICALS INC2012-09-25ANDA200892_001
4NDA012380ZARONTINPARKE DAVIS DIV WARNER LAMBERT CONDA012380_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040430_001RXETHOSUXIMIDE (250MG)ORALCAPSULEFalseAB2002-10-28ETHOSUXIMIDE
2ANDA040686_001RXETHOSUXIMIDE (250MG)ORALCAPSULEFalseAB2008-05-28ETHOSUXIMIDE
3ANDA200892_001RXETHOSUXIMIDE (250MG)ORALCAPSULEFalseAB2012-09-25ETHOSUXIMIDE
4NDA012380_001RXETHOSUXIMIDE (250MG)ORALCAPSULETrueABZARONTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101e8e8ee-b19f-4b3f-a140-9c7391393e1c (view SPL)Ethosuximide Capsules, USPprescriptionHuman PrescriptionVersapharm IncorporatedMANUFACTURE2014-10-033617480025
20d0965f7-d780-4d1c-8ecf-77387483cc02 (view SPL)Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-05-101231550532
30e008f33-70a1-4bc6-b3a0-d45214418ab6 (view SPL)Zarontin (Ethosuximide Capsules, USP)prescriptionHuman PrescriptionParke-Davis Div Of Pfizer IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-07-0914000710237
44b61118d-1046-4510-b327-0f8d41acd156 (view SPL)Ethosuximide Capsules, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-09-162597622250
59d2075a7-8b88-42d5-8df5-05e4ca72f4b2 (view SPL)Ethosuximide Capsules, USPprescriptionHuman PrescriptionPliva Inc.2012-09-189501110901
6bfb2be16-9fe1-48bd-b054-25e2b1ed7a20 (view SPL)Ethosuximide Capsules, USPprescriptionHuman PrescriptionBanner Life Sciences Llc.MANUFACTURE2015-05-151693870108
7cb5577e2-e906-438f-b13d-e55709a0e7fd (view SPL)Ethosuximide Capsules,USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2012-05-301683820443

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII