Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217213
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHSUXIMIDE | METHSUXIMIDE | 300MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/01/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217213Orig1s000ltr.pdf |
METHSUXIMIDE
CAPSULE;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CELONTIN | METHSUXIMIDE | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 010596 | PARKE DAVIS |
METHSUXIMIDE | METHSUXIMIDE | 300MG | CAPSULE;ORAL | Prescription | No | AB | 217213 | NOVITIUM PHARMA |