Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204395
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 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
04/15/2016 ORIG-1 Approval

Label is not available on this site.

SODIUM PHENYLBUTYRATE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPHENYL SODIUM PHENYLBUTYRATE 500MG TABLET;ORAL Prescription Yes AB 020572 HORIZON PHARMA INC
SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 500MG TABLET;ORAL Prescription No AB 090910 ALVOGEN MALTA
SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 500MG TABLET;ORAL Prescription No AB 204395 PAR PHARM

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