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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040866
Company: AMNEAL PHARM

Products on ANDA 040866

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 040866

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	REMS-Proposal, Labeling-Package Insert		Label is not available on this site.
03/29/2011	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels, 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.

Therapeutic Equivalents for ANDA 040866

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	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

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

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