Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083551
Company: WATSON LABS

Products on ANDA 083551

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRIMIDONE	PRIMIDONE	250MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083551

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/1979	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
09/23/2025	SUPPL-51	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/30/2011	SUPPL-42	REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/20/2010	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
04/25/2001	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
07/03/2000	SUPPL-23	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
05/01/1992	SUPPL-21	Labeling		Label is not available on this site.
02/27/1992	SUPPL-20	Labeling		Label is not available on this site.
01/28/1991	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/29/1988	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/29/1988	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/29/1988	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/19/1985	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/19/1985	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/19/1985	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 083551

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	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