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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 200892


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NDA 200892 describes ETHOSUXIMIDE, which is a drug marketed by Bionpharma, Epic Pharma Llc, Heritage Pharms Inc, Puracap Pharm Llc, Strides Pharma, Mikart, Pharm Assoc, and Teva Pharms, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the ETHOSUXIMIDE profile page.

The generic ingredient in ETHOSUXIMIDE is ethosuximide. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethosuximide profile page.
Summary for 200892
Tradename:ETHOSUXIMIDE
Applicant:Heritage Pharms Inc
Ingredient:ethosuximide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200892
Medical Subject Heading (MeSH) Categories for 200892
Suppliers and Packaging for NDA: 200892
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETHOSUXIMIDE ethosuximide CAPSULE;ORAL 200892 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-532 23155-532-01 100 CAPSULE in 1 BOTTLE (23155-532-01)
ETHOSUXIMIDE ethosuximide CAPSULE;ORAL 200892 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-532 23155-532-05 500 CAPSULE in 1 BOTTLE (23155-532-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Sep 25, 2012TE:ABRLD:No

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