Details for New Drug Application (NDA): 210654
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NDA 210654 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 seven 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. Nine suppliers are listed for this compound. 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. Nine suppliers are listed for this compound. Additional details are available on the ethosuximide profile page.
Summary for 210654
| Tradename: | ETHOSUXIMIDE |
| Applicant: | Puracap Pharm Llc |
| Ingredient: | ethosuximide |
| Patents: | 0 |
Pharmacology for NDA: 210654
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 210654
Suppliers and Packaging for NDA: 210654
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETHOSUXIMIDE | ethosuximide | CAPSULE;ORAL | 210654 | ANDA | Epic Pharma, LLC | 42806-708 | 42806-708-01 | 100 CAPSULE in 1 BOTTLE (42806-708-01) |
| ETHOSUXIMIDE | ethosuximide | CAPSULE;ORAL | 210654 | ANDA | Epic Pharma, LLC | 42806-711 | 42806-711-01 | 100 CAPSULE in 1 BOTTLE (42806-711-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Mar 16, 2020 | TE: | AB | RLD: | No | ||||
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