Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008845
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUELICIN SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
QUELICIN PRESERVATIVE FREE SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Discontinued None Yes No
QUELICIN PRESERVATIVE FREE SUCCINYLCHOLINE CHLORIDE 50MG/ML INJECTABLE;INJECTION Discontinued None No No
QUELICIN PRESERVATIVE FREE SUCCINYLCHOLINE CHLORIDE 100MG/ML 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
05/01/1953 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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-73 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008845s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008845Orig1s073Ltr.pdf
07/30/2014 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

03/19/2013 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

11/22/2010 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008845s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/008845s065ltr.pdf
12/17/2002 SUPPL-55 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/17/2000 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/2000 SUPPL-53 Labeling

Label is not available on this site.

01/29/1999 SUPPL-52 Labeling

Label is not available on this site.

05/26/1998 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

01/29/1999 SUPPL-49 Labeling

Label is not available on this site.

10/27/1997 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/28/1994 SUPPL-47 Labeling

Label is not available on this site.

05/03/1989 SUPPL-46 Labeling

Label is not available on this site.

05/03/1989 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1988 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/16/1987 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/01/1987 SUPPL-42 Labeling

Label is not available on this site.

09/01/1987 SUPPL-41 Labeling

Label is not available on this site.

09/01/1987 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/27/1984 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1982 SUPPL-34 Labeling

Label is not available on this site.

10/23/1981 SUPPL-33 Labeling

Label is not available on this site.

11/10/1981 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1981 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1981 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/03/1980 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1982 SUPPL-28 Labeling

Label is not available on this site.

09/03/1980 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1980 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1980 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/11/1979 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1978 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1978 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1977 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1977 SUPPL-19 Labeling

Label is not available on this site.

09/06/1977 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1976 SUPPL-17 Labeling

Label is not available on this site.

12/14/1976 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1976 SUPPL-15 Labeling

Label is not available on this site.

12/14/1976 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/06/1976 SUPPL-13 Labeling

Label is not available on this site.

05/06/1976 SUPPL-12 Labeling

Label is not available on this site.

06/22/1976 SUPPL-11 Manufacturing (CMC)-Control

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-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008845s073lbl.pdf
07/26/2018 SUPPL-73 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008845s073lbl.pdf
11/22/2010 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008845s065lbl.pdf

QUELICIN

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
SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 211432 AMNEAL
SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 210231 AMRING PHARMS
SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 210698 DR REDDYS
SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 212638 GPP
SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 209467 ZYDUS PHARMS

QUELICIN PRESERVATIVE FREE

There are no Therapeutic Equivalents.

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