Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 Yes Yes
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 Type 1 - New Molecular Entity STANDARD; 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
12/03/2014 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/25/2016 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/12/2013 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/10/2013 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/12/2009 SUPPL-36 Labeling 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 Labeling 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 Manufacturing (CMC) 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 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/2002 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/23/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/24/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/14/1999 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1999 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/29/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1994 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/10/1995 SUPPL-4 Labeling

Label is not available on this site.

09/09/1992 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/17/1992 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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