Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040862
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIMIDONE PRIMIDONE 50MG TABLET;ORAL Discontinued None No No
PRIMIDONE PRIMIDONE 250MG TABLET;ORAL Discontinued None 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
10/03/2008 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
11/17/2011 SUPPL-4 REMS

Label is not available on this site.

09/20/2011 SUPPL-2 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

11/30/2010 SUPPL-1 Labeling

Label is not available on this site.

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