Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084903
Company: LANNETT

Products on ANDA 084903

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084903

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.

Therapeutic Equivalents for ANDA 084903

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