Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083551
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIMIDONE PRIMIDONE 250MG TABLET;ORAL Prescription AB No No
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
03/30/2011 SUPPL-42 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

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.

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 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

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