Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218366
Company: CARNEGIE
Company: CARNEGIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRIMIDONE | PRIMIDONE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
PRIMIDONE | PRIMIDONE | 250MG | TABLET;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 |
---|---|---|---|---|---|---|---|
01/23/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PRIMIDONE
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MYSOLINE | PRIMIDONE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 009170 | VALEANT |
PRIMIDONE | PRIMIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 040866 | AMNEAL PHARM |
PRIMIDONE | PRIMIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 040626 | ANDA REPOSITORY |
PRIMIDONE | PRIMIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 218366 | CARNEGIE |
PRIMIDONE | PRIMIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 084903 | LANNETT |
PRIMIDONE | PRIMIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 040586 | OXFORD PHARMS |
PRIMIDONE | PRIMIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 214896 | RUBICON |
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MYSOLINE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | Yes | AB | 009170 | VALEANT |
PRIMIDONE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | No | AB | 040866 | AMNEAL PHARM |
PRIMIDONE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | No | AB | 040626 | ANDA REPOSITORY |
PRIMIDONE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | No | AB | 218366 | CARNEGIE |
PRIMIDONE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | No | AB | 084903 | LANNETT |
PRIMIDONE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | No | AB | 040586 | OXFORD PHARMS |
PRIMIDONE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | No | AB | 214896 | RUBICON |
PRIMIDONE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | No | AB | 083551 | WATSON LABS |