Drugs@FDA: FDA-Approved Drugs
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/2021/020032Orig1s047lbl.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/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 |