Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIMBEX | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
12/15/1995 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/07/2022 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
10/14/2022 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020551s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020551Orig1s028ltr.pdf | |
07/26/2018 | SUPPL-26 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/20551Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020551Orig1s020s026Ltr.pdf | |
04/01/2013 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/26/2018 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/20551Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020551Orig1s020s026Ltr.pdf | |
11/22/2010 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020551s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020551s019ltr.pdf | |
06/02/2010 | SUPPL-17 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020551s017ltr.pdf |
10/15/2002 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/04/2002 | SUPPL-10 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20551s010ltr.pdf |
07/18/2003 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20551se8-009ltr.pdf |
02/25/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
02/25/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
03/26/1999 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/21/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
05/21/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
10/15/1998 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
06/19/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/14/2022 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020551s028lbl.pdf | |
07/26/2018 | SUPPL-26 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/20551Orig1s026lbl.pdf | |
07/26/2018 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/20551Orig1s026lbl.pdf | |
07/26/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/20551Orig1s026lbl.pdf | |
11/22/2010 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020551s019lbl.pdf |