Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040866
Company: AMNEAL PHARM
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
04/23/2008 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
10/19/2012 SUPPL-9 Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

03/29/2011 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

11/30/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/20/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/21/2009 SUPPL-1 Labeling

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 084903 LANNETT
PRIMIDONE PRIMIDONE 50MG TABLET;ORAL Prescription No AB 040586 OXFORD PHARMS

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

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