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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009170
Company: VALEANT

Medication Guide

Products on NDA 009170

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYSOLINE	PRIMIDONE	250MG	TABLET;ORAL	Prescription	AB	Yes	No
MYSOLINE	PRIMIDONE	50MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009170

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/08/1954	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2020	SUPPL-40	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009170Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009170Orig1s040ltr.pdf
02/19/2016	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
08/10/2011	SUPPL-38	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009170s038ltr.pdf
04/23/2009	SUPPL-36	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009170s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s036ltr.pdf
07/21/2010	SUPPL-35	Labeling, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009170s035ltr.pdf
05/08/2009	SUPPL-34	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/09170_S034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s034ltr.pdf
01/29/2009	SUPPL-33	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s033ltr.pdf
06/13/2008	SUPPL-31	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/009170s031ltr.pdf
05/06/2002	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
12/14/2000	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/10/2000	SUPPL-19	Labeling		Label is not available on this site.
03/18/1994	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/1989	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
07/28/1988	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/02/1987	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
08/11/1989	SUPPL-13	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/20/1982	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
01/28/1982	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/1981	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 009170

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2020	SUPPL-40	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009170Orig1s040lbl.pdf
07/21/2010	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035lbl.pdf
07/21/2010	SUPPL-35	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035lbl.pdf
05/08/2009	SUPPL-34	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/09170_S034lbl.pdf
05/08/2009	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/09170_S034lbl.pdf
04/23/2009	SUPPL-36	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009170s036lbl.pdf

Therapeutic Equivalents for NDA 009170

MYSOLINE

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

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