Drugs@FDA: FDA-Approved Drugs
Company: LANNETT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRIMIDONE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | AB | No | No |
PRIMIDONE | PRIMIDONE | 50MG | 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 |
---|---|---|---|---|---|---|---|
12/01/1978 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/01/2012 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
05/20/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
10/03/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/13/2001 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
06/25/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/24/2001 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/24/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
05/24/2001 | SUPPL-15 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
08/10/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
08/04/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/18/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/11/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/14/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
11/09/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
06/28/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/21/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
PRIMIDONE
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 |
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 |