An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040626
Company: TP ANDA HOLDINGS

Products on ANDA 040626

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040626

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2005	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
12/23/2010	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/10/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/20/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040626

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	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 RESEARCH
PRIMIDONE	PRIMIDONE	50MG	TABLET;ORAL	Prescription	No	AB	040626	TP ANDA HOLDINGS

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	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 RESEARCH
PRIMIDONE	PRIMIDONE	250MG	TABLET;ORAL	Prescription	No	AB	040626	TP ANDA HOLDINGS
PRIMIDONE	PRIMIDONE	250MG	TABLET;ORAL	Prescription	No	AB	083551	WATSON LABS

Top