Details for New Drug Application (NDA): 217213
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NDA 217213 describes METHSUXIMIDE, which is a drug marketed by Novitium Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the METHSUXIMIDE profile page.
The generic ingredient in METHSUXIMIDE 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 METHSUXIMIDE 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 217213
| Tradename: | METHSUXIMIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | methsuximide |
| Patents: | 0 |
Pharmacology for NDA: 217213
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 217213
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHSUXIMIDE | methsuximide | CAPSULE;ORAL | 217213 | ANDA | ANI Pharmaceuticals, Inc. | 70954-228 | 70954-228-10 | 100 CAPSULE in 1 BOTTLE (70954-228-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | May 1, 2023 | TE: | AB | RLD: | No | ||||
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