Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080966
Company: LANNETT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROBALAN PROBENECID 500MG 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
07/29/1976 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
05/15/2006 SUPPL-23 Labeling

Label is not available on this site.

08/18/1989 SUPPL-18 Labeling

Label is not available on this site.

03/11/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

PROBALAN

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROBALAN PROBENECID 500MG TABLET;ORAL Prescription No AB 080966 LANNETT
PROBENECID PROBENECID 500MG TABLET;ORAL Prescription No AB 084211 MYLAN

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