Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203918
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER;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
06/15/2016 ORIG-1 Approval

Label is not available on this site.

SODIUM PHENYLBUTYRATE

POWDER;ORAL; 3GM/TEASPOONFUL
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPHENYL SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER;ORAL Prescription Yes AB 020573 HORIZON PHARMA INC
SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER;ORAL Prescription No AB 203918 PAR PHARM
SODIUM PHENYLBUTYRATE SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL POWDER;ORAL Prescription No AB 202819 SIGMAPHARM LABS LLC

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