Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020032
Company: ABBVIE

• This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 20032

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SURVANTA	BERACTANT	25MG/ML	SUSPENSION;INTRATRACHEAL	Prescription	None	No	No

Labels for BLA 020032

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/15/2022	SUPPL-47	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020032Orig1s047lbl.pdf
10/26/2020	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020032s046lbl.pdf
10/26/2020	SUPPL-46	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020032s046lbl.pdf
12/16/2019	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020032s045lbl.pdf