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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761201
Company: MYLAN PHARMS INC

Products on BLA 761201

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEMGLEE	INSULIN GLARGINE-YFGN	10ML(100UNITS/ML)	INJECTABLE;INJECTION	Prescription	None	No	No
SEMGLEE	INSULIN GLARGINE-YFGN	3ML(100UNITS/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761201

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2021	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761201Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761201Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761201Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/25/2024	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761201s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761201Orig1s010ltr.pdf
11/29/2023	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761201Orig1s008ltr.pdf
05/30/2023	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761201Orig1s007ltr.pdf

Labels for BLA 761201

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/25/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761201s010lbl.pdf
11/25/2024	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761201s010lbl.pdf
11/29/2023	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s008lbl.pdf
05/30/2023	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s007lbl.pdf
05/30/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s007lbl.pdf
05/30/2023	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s007lbl.pdf
07/28/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761201Orig1s000lbl.pdf

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