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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022536
Company: FRESENIUS KABI USA

Summary Review

Products on NDA 022536

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN	INDOMETHACIN	EQ 1MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022536

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022536lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022536s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022536_indomethacin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022536s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2021	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022536Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022536Orig1s008ltr.pdf
06/05/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022536

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022536Orig1s008lbl.pdf
12/21/2021	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022536Orig1s008lbl.pdf
03/17/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022536lbl.pdf

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