Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204767
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;IV (INFUSION) Prescription None 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
10/28/2015 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204767s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204767Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204767Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/28/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204767s000lbl.pdf

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