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FDA ANDA · ANDA204433
DIAZEPAM
diazepam oral solution (concentrate)
Sponsor: CHARTWELL MOLECULAR
APPLICATION
ANDA204433
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-14
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
DIAZEPAMPrescription
DIAZEPAM 5MG/ML · CONCENTRATE · ORAL
Approval history
2023-01-17Labeling · Supplement 9 · standardAP
2021-02-05Labeling · Supplement 6 · standardAP
2021-02-04Labeling · Supplement 3 · standardAP
2016-03-24Labeling · Supplement 2 · standardAP
2014-04-14UNKNOWN · OriginalAP
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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