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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761125
Company: NOVARTIS PHARMS CORP

Products on BLA 761125

CSV Excel Print

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BEOVU	brolucizumab-dbll	6MG/0.05ML	INJECTABLE; INTRAVITREAL	Prescription	None	No	No

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Approval Date(s) and History, Letters, Labels, Reviews for BLA 761125

Original Approvals or Tentative Approvals

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Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
10/07/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review

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Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
07/29/2024	SUPPL-21	Supplement	Label (PDF) Letter (PDF)
09/28/2023	SUPPL-20	Supplement	Label (PDF) Letter (PDF)
12/19/2022	SUPPL-17	Supplement	Label (PDF) Letter (PDF)
05/27/2022	SUPPL-8	Supplement	Label (PDF) Letter (PDF)
03/09/2022	SUPPL-2	Supplement		Label is not available on this site.
02/18/2022	SUPPL-13	Supplement	Label (PDF) Letter (PDF)
02/18/2022	SUPPL-12	Supplement	Label (PDF) Letter (PDF)
02/18/2022	SUPPL-10	Supplement	Label (PDF) Letter (PDF)
06/09/2020	SUPPL-4	Supplement	Label (PDF) Letter (PDF) Review (PDF)

Showing 1 to 9 of 9 entries

Labels for BLA 761125

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
07/29/2024	SUPPL-21	Labeling-Package Insert	Label (PDF)
09/28/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)
12/19/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)
05/27/2022	SUPPL-8	Efficacy-New Indication	Label (PDF)
02/18/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)
02/18/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)
02/18/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)
06/09/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)
10/07/2019	ORIG-1	Approval	Label (PDF)

Showing 1 to 9 of 9 entries

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