APPLICATION
NDA008453
TYPE
NDA
ORIGINAL APPROVAL
1952-08-20
LATEST ACTION
2023-11-21
ROUTE
INTRAMUSCULAR, INTRAVENOUS, PARENTERAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
ANECTINEDiscontinued
SUCCINYLCHOLINE CHLORIDE 1GM/VIAL · INJECTABLE · INJECTION
ANECTINE · ReferencePrescription
SUCCINYLCHOLINE CHLORIDE 20MG/ML · INJECTABLE · INJECTION
ANECTINEDiscontinued
SUCCINYLCHOLINE CHLORIDE 50MG/ML · INJECTABLE · INJECTION
ANECTINEDiscontinued
SUCCINYLCHOLINE CHLORIDE 500MG/VIAL · INJECTABLE · INJECTION
Approval history
2023-11-21Labeling · Supplement 41 · standardAP
2017-06-23Manufacturing (CMC) · Supplement 33AP
2016-01-25Manufacturing (CMC) · Supplement 32 · priorityAP
2013-01-17Manufacturing (CMC) · Supplement 30 · priorityAP
2000-10-02Labeling · Supplement 19 · standardAP
2000-09-26Labeling · Supplement 16 · standardAP
1997-04-10Manufacturing (CMC) · Supplement 18 · priorityAP
1994-11-28Labeling · Supplement 17 · standardAP
1993-10-29Labeling · Supplement 15 · standardAP
1987-11-10Labeling · Supplement 14AP
1985-05-22Manufacturing (CMC) · Supplement 7 · priorityAP
1985-05-01Labeling · Supplement 13AP
1981-12-22Labeling · Supplement 9AP
1981-05-15Manufacturing (CMC) · Supplement 11 · priorityAP
1981-02-12Manufacturing (CMC) · Supplement 10 · priorityAP
1980-11-21Manufacturing (CMC) · Supplement 8 · priorityAP
1952-08-20Type 1 - New Molecular Entity · Original · priorityAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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