APPLICATION
ANDA078378
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-24
LATEST ACTION
2024-11-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
REVONTOPrescription
DANTROLENE SODIUM 20MG/VIAL · INJECTABLE · INJECTION
Approval history
2024-11-22Labeling · Supplement 21 · standardAP
2015-05-27Labeling · Supplement 9 · standardAP
2010-02-16Labeling · Supplement 5AP
2010-02-16Labeling · Supplement 6AP
2010-02-16Labeling · Supplement 4AP
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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