Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211928
Company: STRIDES PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/19/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

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 040686 AKORN
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 040430 BIONPHARMA INC
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 200892 HERITAGE PHARMS INC
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 211928 STRIDES PHARMA
ZARONTIN ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription Yes AB 012380 PARKE DAVIS

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