APPLICATION
NDA020214
TYPE
NDA
ORIGINAL APPROVAL
1994-03-17
LATEST ACTION
2018-07-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ZEMURON · ReferenceDiscontinued
ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZEMURON · ReferenceDiscontinued
ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZEMURON · ReferenceDiscontinued
ROCURONIUM BROMIDE 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2013-04-29Manufacturing (CMC) · Supplement 35 · standardAP
2001-07-20Manufacturing (CMC) · Supplement 15 · standardAP
2001-06-05Labeling · Supplement 13 · standardAP
2000-03-27Labeling · Supplement 8 · standardAP
2000-03-27Labeling · Supplement 10 · standardAP
1999-03-17Manufacturing (CMC) · Supplement 9 · standardAP
1997-12-03Manufacturing (CMC) · Supplement 6 · standardAP
1997-06-30Manufacturing (CMC) · Supplement 7 · standardAP
1996-07-25Manufacturing (CMC) · Supplement 5 · standardAP
1996-06-21Manufacturing (CMC) · Supplement 4 · standardAP
1995-10-04Manufacturing (CMC) · Supplement 2 · standardAP
1994-12-07Labeling · Supplement 3 · standardAP
1994-11-22Manufacturing (CMC) · Supplement 1 · standardAP
1994-03-17Type 1 - New Molecular Entity · Original · standardAP
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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