Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008453
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANECTINE SUCCINYLCHOLINE CHLORIDE 500MG/VIAL INJECTABLE;INJECTION Discontinued None No No
ANECTINE SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
ANECTINE SUCCINYLCHOLINE CHLORIDE 50MG/ML INJECTABLE;INJECTION Discontinued None No No
ANECTINE SUCCINYLCHOLINE CHLORIDE 1GM/VIAL INJECTABLE;INJECTION Discontinued 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
08/20/1952 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/23/2017 SUPPL-33 Labeling-Container/Carton Labels

Label is not available on this site.

01/25/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/17/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/22/2010 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/008453s027ltr.pdf
10/02/2000 SUPPL-19 Labeling

Label is not available on this site.

04/10/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/28/1994 SUPPL-17 Labeling

Label is not available on this site.

09/26/2000 SUPPL-16 Labeling

Label is not available on this site.

10/29/1993 SUPPL-15 Labeling

Label is not available on this site.

11/10/1987 SUPPL-14 Labeling

Label is not available on this site.

05/01/1985 SUPPL-13 Labeling

Label is not available on this site.

02/11/1982 SUPPL-12 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf
05/15/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1981 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1981 SUPPL-9 Labeling

Label is not available on this site.

11/21/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1985 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/30/1978 SUPPL-6 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf
12/05/1975 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf
06/22/1973 SUPPL-1 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/22/2010 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf

ANECTINE

INJECTABLE;INJECTION; 20MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANECTINE SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription Yes AP 008453 SANDOZ INC
QUELICIN SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription Yes AP 008845 HOSPIRA
QUELICIN PRESERVATIVE FREE SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription Yes AP 008845 HOSPIRA

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