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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125553
Company: SANDOZ INC

Summary Review

Products on BLA 125553

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZARXIO	FILGRASTIM-SNDZ	300 mcg/0.5 mL	INJECTABLE;INJECTION	Prescription	None	No	No
ZARXIO	FILGRASTIM-SNDZ	480 mcg/0.8 mL	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125553

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125553Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2024	SUPPL-38	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125553s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125553Orig1s038ltr.pdf
01/19/2024	SUPPL-36	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125553Orig1s036IFU.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125553Orig1s036ltr.pdf
08/09/2024	SUPPL-35	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125553s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125553Orig1s035ltr.pdf
07/26/2021	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125553s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125553Orig1s023ltr.pdf
08/01/2019	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125553s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125553Orig1s017ltr.pdf
02/17/2017	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125553s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125553Orig1s007ltr.pdf
03/03/2016	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125553s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125553Orig1s001ltr.pdf

Labels for BLA 125553

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2024	SUPPL-38	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125553s038lbl.pdf
10/22/2024	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125553s038lbl.pdf
08/09/2024	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125553s035lbl.pdf
01/19/2024	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125553Orig1s036IFU.pdf
07/26/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125553s023lbl.pdf
07/26/2021	SUPPL-23	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125553s023lbl.pdf
08/01/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125553s017lbl.pdf
02/17/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125553s007lbl.pdf
02/17/2017	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125553s007lbl.pdf
02/17/2017	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125553s007lbl.pdf
03/03/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125553s001lbl.pdf
03/06/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553Orig1s000lbl.pdf

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