Drugs@FDA: FDA-Approved Drugs

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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;INTRAVENOUS 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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/28/2021 SUPPL-8 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204767Orig1s008ltr.pdf
06/23/2021 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204767s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204767Orig1s007ltr.pdf
11/13/2020 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204767s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204767Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/23/2021 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204767s007lbl.pdf
11/13/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204767s003lbl.pdf
10/28/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204767s000lbl.pdf

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