Ethosuximide Oral Solution

Brand(s)
Zarontin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Parke-Davis Div Of Pfizer Inc (2014-05-15)
Oldest Current Product
1994-07-01
License(s)
ANDA
RxNORM
ORAL SOLUTION\ETHOSUXIMIDE
FDAOB
ORAL\SYRUP\ETHOSUXIMIDE
SPL Active
ORAL\SOLUTION\ETHOSUXIMIDE
SPL Moiety
ORAL\SOLUTION\ETHOSUXIMIDE

product(s) by strength(s)

ethosuximide 50 mg/ml oral solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000712418ZarontinANDAParke-Davis Div Of Pfizer Inc2002-02-27ETHOSUXIMIDEORALSOLUTIONANDA0802587bf3e616-45e8-4469-a75d-4d824ce951ea
2000939660ANDATeva Pharmaceuticals Usa Inc1994-07-01ETHOSUXIMIDEORALSOLUTIONANDA081306b2f96a67-75a5-4c9e-a706-b88114d15a17
3001210670ANDAPharmaceutical Associates, Inc.2000-11-22ETHOSUXIMIDEORALSOLUTIONANDA0402538a5cc930-0b36-48a8-9ad0-de633b208742
4466720641ANDAMikart, Inc.2003-12-22ETHOSUXIMIDEORALSOLUTIONANDA040506e7d4b2a4-2dae-4026-a381-9d534d36c6b3
5597622350ANDAGreenstone Llc2002-02-27ETHOSUXIMIDEORALSOLUTIONANDA08025819c924c2-f558-4c78-9277-2d7e0df2f505
6617480024ANDAVersapharm Incorporated2004-01-01ETHOSUXIMIDEORALSOLUTIONANDA0405062b8dd7cd-03a5-47a3-955a-03b6b08555b5

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA040253ETHOSUXIMIDEPHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS2000-11-22ANDA040253_001
2ANDA040506ETHOSUXIMIDEMIKART INC2003-12-22ANDA040506_001
3ANDA080258ZARONTINPARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT COANDA080258_001
4ANDA081306ETHOSUXIMIDETEVA PHARMACEUTICALS USA1993-07-30ANDA081306_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040253_001RXETHOSUXIMIDE (250MG/5ML)ORALSYRUPFalseAA2000-11-22ETHOSUXIMIDE
2ANDA040506_001RXETHOSUXIMIDE (250MG/5ML)ORALSYRUPFalseAA2003-12-22ETHOSUXIMIDE
3ANDA080258_001RXETHOSUXIMIDE (250MG/5ML)ORALSYRUPTrueAAZARONTIN
4ANDA081306_001RXETHOSUXIMIDE (250MG/5ML)ORALSYRUPFalseAA1993-07-30ETHOSUXIMIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
119c924c2-f558-4c78-9277-2d7e0df2f505 (view SPL)Ethosuximide ORAL SOLUTIONprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-09-162597622350
22b8dd7cd-03a5-47a3-955a-03b6b08555b5 (view SPL)ETHOSUXIMIDE ORAL SOLUTION, USP 250 mg/5 mLprescriptionHuman PrescriptionVersapharm IncorporatedMANUFACTURE2014-11-132617480024
37bf3e616-45e8-4469-a75d-4d824ce951ea (view SPL)Zarontin (Ethosuximide) ORAL SOLUTIONprescriptionHuman PrescriptionParke-Davis Div Of Pfizer IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-05-1512000712418
48a5cc930-0b36-48a8-9ad0-de633b208742 (view SPL)Ethosuximide Oral Solution USPprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2014-06-164001210670
5b2f96a67-75a5-4c9e-a706-b88114d15a17 (view SPL)ETHOSUXIMIDE ORAL SOLUTION USP9660Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-03-265000939660
6e7d4b2a4-2dae-4026-a381-9d534d36c6b3 (view SPL)prescriptionHuman PrescriptionMikart, Inc.2014-05-273466720641

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