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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761173
Company: FRESENIUS KABI USA

Products on BLA 761173

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STIMUFEND	PEGFILGRASTIM-FPGK	6MG/0.6ML	SOLUTION; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761173

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/01/2022	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761173Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761173Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761173Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2025	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761173Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761173Orig1s013ltr.pdf
03/26/2025	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761173s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761173Orig1s008ltr.pdf
09/29/2023	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761173s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761173Orig1s002ltr.pdf

Labels for BLA 761173

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761173Orig1s013lbl.pdf
10/21/2025	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761173Orig1s013lbl.pdf
03/26/2025	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761173s008lbl.pdf
03/26/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761173s008lbl.pdf
09/29/2023	SUPPL-2		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761173s002lbl.pdf
09/01/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761173Orig1s000correctedlbl.pdf

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