Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209359
Company: HOSPIRA

Products on NDA 209359

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPINEPHRINE	EPINEPHRINE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209359

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2019	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209359s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209359Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209359Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/25/2022	SUPPL-7	Manufacturing (CMC)-Manufacturing Process	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209359Orig1s007ltr.pdf
09/29/2022	SUPPL-6	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209359Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209359Orig1s006ltr.pdf

Labels for NDA 209359

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2022	SUPPL-6	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209359Orig1s006lbl.pdf
11/05/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209359s000lbl.pdf