Details for New Drug Application (NDA): 010596
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NDA 010596 describes CELONTIN, which is a drug marketed by Parke Davis and is included in one NDA. It is available from one supplier. Additional details are available on the CELONTIN profile page.
The generic ingredient in CELONTIN is methsuximide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the methsuximide profile page.
The generic ingredient in CELONTIN is methsuximide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the methsuximide profile page.
Summary for 010596
| Tradename: | CELONTIN |
| Applicant: | Parke Davis |
| Ingredient: | methsuximide |
| Patents: | 0 |
Pharmacology for NDA: 010596
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 010596
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CELONTIN | methsuximide | CAPSULE;ORAL | 010596 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0525 | 0071-0525-24 | 100 CAPSULE in 1 BOTTLE (0071-0525-24) |
Profile for product number 007
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 008
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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