An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 210282
Company: HOSPIRA

Products on NDA 210282

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210282

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2021	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210282Orig1s000LblEdit.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210282Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/210282Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2025	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210282s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210282Orig1s004ltr.pdf
08/08/2022	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210282s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210282Orig1s001ltr.pdf

Labels for NDA 210282

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210282s004lbl.pdf
08/08/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210282s001lbl.pdf
06/21/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210282Orig1s000LblEdit.pdf

Top