Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213976
Company: TAKEDA PHARMS USA

Products on NDA 213976

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EOHILIA	BUDESONIDE	2MG/10ML	SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213976

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/09/2024	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213976s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213976Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/213976Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/16/2024	SUPPL-1	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213976s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213976Orig1s001ltr.pdf

Labels for NDA 213976

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/16/2024	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213976s001lbl.pdf
05/16/2024	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213976s001lbl.pdf
05/16/2024	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213976s001lbl.pdf
02/09/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213976s000lbl.pdf