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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020032
Company: ABBVIE

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/01/1991 ORIG-1 Approval N/A; Orphan

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2022 SUPPL-47 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020032Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020032Orig1s047ltr.pdf
10/26/2020 SUPPL-46 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020032s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020032Orig1s046ltr.pdf
12/16/2019 SUPPL-45 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020032s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020032Orig1s045ltr.pdf
12/03/2014 SUPPL-44 Supplement

Label is not available on this site.
02/25/2016 SUPPL-43 Supplement

Label is not available on this site.
06/12/2013 SUPPL-42 Supplement

Label is not available on this site.
04/10/2013 SUPPL-41 Supplement

Label is not available on this site.
01/12/2009 SUPPL-36 Supplement Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020032s036ltr.pdf
02/10/2009 SUPPL-35 Supplement Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020032s035ltr.pdf
04/28/2005 SUPPL-26 Supplement Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020032s026ltr.pdf
12/06/2002 SUPPL-23 Supplement

Label is not available on this site.
04/30/2002 SUPPL-20 Supplement

Label is not available on this site.
03/23/2001 SUPPL-19 Supplement

Label is not available on this site.
11/27/2000 SUPPL-18 Supplement

Label is not available on this site.
08/25/2000 SUPPL-17 Supplement

Label is not available on this site.
12/12/2000 SUPPL-15 Supplement

Label is not available on this site.
02/24/2000 SUPPL-14 Supplement

Label is not available on this site.
10/14/1999 SUPPL-13 Supplement

Label is not available on this site.
06/16/1999 SUPPL-12 Supplement

Label is not available on this site.
10/20/1999 SUPPL-11 Supplement

Label is not available on this site.
12/09/1998 SUPPL-10 Supplement

Label is not available on this site.
04/04/1996 SUPPL-9 Supplement

Label is not available on this site.
09/27/1994 SUPPL-8 Supplement

Label is not available on this site.
09/06/1994 SUPPL-7 Supplement

Label is not available on this site.
08/29/1994 SUPPL-6 Supplement

Label is not available on this site.
07/28/1994 SUPPL-5 Supplement

Label is not available on this site.
03/10/1995 SUPPL-4 Supplement

Label is not available on this site.
09/09/1992 SUPPL-3 Supplement

Label is not available on this site.
03/24/1994 SUPPL-2 Supplement

Label is not available on this site.
08/17/1992 SUPPL-1 Supplement

Label is not available on this site.

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/2022/020032Orig1s047lbl.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
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