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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204767
Company: FRESENIUS KABI USA

Products on NDA 204767

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204767

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

Labels for NDA 204767

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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