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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125294
Company: SICOR BIOTECH

Summary Review

Products on BLA 125294

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRANIX	TBO-FILGRASTIM	300MCG/0.5ML	INJECTABLE; INJECTION	Prescription	None	No	No
GRANIX	TBO-FILGRASTIM	480MCG/0.8ML	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125294

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2012	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125294s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125294Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2023	SUPPL-58	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125294s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125294Orig1s058ltr.pdf
10/09/2019	SUPPL-48	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125294Orig1s048ltr.pdf
03/28/2019	SUPPL-46	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125294s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125294Orig1s046ltr.pdf
07/31/2018	SUPPL-45	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125294s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125294Orig1s045ltr.pdf
06/21/2017	SUPPL-42	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125294Orig1s042ltr.pdf
02/02/2017	SUPPL-40	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125294Orig1s040ltr.pdf
12/19/2014	SUPPL-35	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf
07/19/2013	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125294s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125294Orig1s007ltr.pdf

Labels for BLA 125294

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2023	SUPPL-58	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125294s058lbl.pdf
03/28/2019	SUPPL-46	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125294s046lbl.pdf
07/31/2018	SUPPL-45	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125294s045lbl.pdf
06/21/2017	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s042lbl.pdf
02/02/2017	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf
02/02/2017	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf
12/19/2014	SUPPL-35	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf
12/19/2014	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf
12/19/2014	SUPPL-35	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf
07/19/2013	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125294s007lbl.pdf
08/29/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125294s0000lbl.pdf

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