Details for New Drug Application (NDA): 080258
✉ Email this page to a colleague
NDA 080258 describes ZARONTIN, which is a drug marketed by Parke Davis and Parke-davis and is included in two NDAs. It is available from two suppliers. Additional details are available on the ZARONTIN profile page.
The generic ingredient in ZARONTIN 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 ZARONTIN 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 080258
| Tradename: | ZARONTIN |
| Applicant: | Parke-davis |
| Ingredient: | ethosuximide |
| Patents: | 0 |
Pharmacology for NDA: 080258
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 080258
Suppliers and Packaging for NDA: 080258
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZARONTIN | ethosuximide | SYRUP;ORAL | 080258 | ANDA | Parke-Davis Div of Pfizer Inc | 0071-2418 | 0071-2418-19 | 1 BOTTLE, PLASTIC in 1 CARTON (0071-2418-19) / 474 mL in 1 BOTTLE, PLASTIC |
| ZARONTIN | ethosuximide | SYRUP;ORAL | 080258 | ANDA | Mylan Pharmaceuticals Inc. | 59762-2350 | 59762-2350-6 | 1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-6) / 474 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes | ||||
Complete Access Available with Subscription
