Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020551
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 Prescription AP Yes Yes
NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
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
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
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

NIMBEX

INJECTABLE;INJECTION; EQ 2MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203183 FRESENIUS KABI USA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 209334 JIANGSU HENGRUI MED
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 200159 SANDOZ INC
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203182 FRESENIUS KABI USA
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204960 JIANGSU HENGRUI MED
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 200154 SANDOZ INC
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206791 SOMERSET THERAPS LLC
NIMBEX CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 020551 ABBVIE
NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 020551 ABBVIE

NIMBEX PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203182 FRESENIUS KABI USA
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204960 JIANGSU HENGRUI MED
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 200154 SANDOZ INC
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206791 SOMERSET THERAPS LLC
NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 020551 ABBVIE

INJECTABLE;INJECTION; EQ 2MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203183 FRESENIUS KABI USA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 209334 JIANGSU HENGRUI MED
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 200159 SANDOZ INC
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203182 FRESENIUS KABI USA
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204960 JIANGSU HENGRUI MED
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 200154 SANDOZ INC
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206791 SOMERSET THERAPS LLC
NIMBEX CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 020551 ABBVIE
NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 020551 ABBVIE

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