Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020645
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMMONUL SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) SOLUTION;IV (INFUSION) Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/17/2005 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020645ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020645s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/10/2017 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/07/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/30/2011 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020645s008ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/30/2011 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s008lbl.pdf
02/17/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf

AMMONUL

SOLUTION;IV (INFUSION); 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;IV (INFUSION) Prescription Yes AP 020645 MEDICIS
SODIUM PHENYLACETATE AND SODIUM BENZOATE SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) SOLUTION;IV (INFUSION) Prescription No AP 207096 AILEX PHARMS LLC
SODIUM PHENYLACETATE AND SODIUM BENZOATE SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) SOLUTION;IV (INFUSION) Prescription No AP 208521 MAIA PHARMS INC
SODIUM PHENYLACETATE AND SODIUM BENZOATE SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) SOLUTION;IV (INFUSION) Prescription No AP 205880 NAVINTA LLC

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