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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205880
Company: NAVINTA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM PHENYLACETATE AND SODIUM BENZOATE SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) SOLUTION;INTRAVENOUS Prescription AP 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
08/04/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205880Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205880Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/04/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205880Orig1s000lbl.pdf

SODIUM PHENYLACETATE AND SODIUM BENZOATE

SOLUTION;INTRAVENOUS; 10%;10% (5GM/50ML;5GM/50ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMMONUL SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) SOLUTION;INTRAVENOUS Prescription Yes AP 020645 BAUSCH
SODIUM PHENYLACETATE AND SODIUM BENZOATE SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) SOLUTION;INTRAVENOUS Prescription No AP 207096 AILEX PHARMS LLC
SODIUM PHENYLACETATE AND SODIUM BENZOATE SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) SOLUTION;INTRAVENOUS Prescription No AP 208521 MAIA PHARMS INC
SODIUM PHENYLACETATE AND SODIUM BENZOATE SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) SOLUTION;INTRAVENOUS Prescription No AP 205880 NAVINTA LLC
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