Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009170
Company: VALEANT
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
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
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-Package Insert, Labeling-Container/Carton Labels 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-Package Insert, Labeling-Container/Carton Labels 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/09170_S034lbl.pdf
05/08/2009 SUPPL-34 Labeling-Container/Carton Labels 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

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 040667 HIKMA INTL PHARMS
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 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 084903 LANNETT
PRIMIDONE PRIMIDONE 50MG TABLET;ORAL Prescription No AB 040586 OXFORD PHARMS

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