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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020551
Company: ABBVIE

Products on NDA 020551

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020551

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.

Labels for NDA 020551

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

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