Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084903
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 040667 HIKMA INTL PHARMS
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 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 084903 LANNETT
PRIMIDONE PRIMIDONE 50MG TABLET;ORAL Prescription No AB 040586 OXFORD PHARMS

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