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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761102
Company: SERVIER PHARMA LLC

Products on BLA 761102

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASPARLAS	CALASPARGASE PEGOL-MKNL	3750UNITS/5ML	INJECTABLE;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761102

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2018	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761102Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761102Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2023	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761102s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761102Orig1s013ltr.pdf
12/21/2021	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761102s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761102Orig1s008ltr.pdf
06/24/2020	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761102s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761102Orig1s003ltr.pdf
09/05/2019	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761102s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761102Orig1s002ltr.pdf

Labels for BLA 761102

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761102s013lbl.pdf
11/29/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761102s013lbl.pdf
12/21/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761102s008lbl.pdf
06/24/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761102s003lbl.pdf
09/05/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761102s002lbl.pdf
12/20/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.pdf

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