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

Biologic License Application (BLA): 761080
Company: HOSPIRA INC

Products on BLA 761080

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIVESTYM	FILGRASTIM-AAFI	300MCG/ML	VIAL;SINGLE-DOSE	Prescription	None	No	No
NIVESTYM	FILGRASTIM-AAFI	480MCG/1.6ML	VIAL;SINGLE-DOSE	Prescription	None	No	No
NIVESTYM	FILGRASTIM-AAFI	300MCG/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
NIVESTYM	FILGRASTIM-AAFI	480MCG/0.8ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761080

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2018	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761080s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761080Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761080Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2024	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761080s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761080Orig1s014ltr.pdf
08/28/2023	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761080s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761080Orig1s011ltr.pdf
05/03/2021	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761080s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761080Orig1s007ltr.pdf

Labels for BLA 761080

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761080s014lbl.pdf
08/28/2023	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761080s011lbl.pdf
05/03/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761080s007lbl.pdf
07/20/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761080s000lbl.pdf

Top