APPLICATION
ANDA040646
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-30
LATEST ACTION
2024-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCORTISONEPrescription
HYDROCORTISONE 20MG · TABLET · ORAL
HYDROCORTISONEPrescription
HYDROCORTISONE 5MG · TABLET · ORAL
HYDROCORTISONEPrescription
HYDROCORTISONE 10MG · TABLET · ORAL
Approval history
2024-09-25Labeling · Supplement 8 · standardAP
2024-09-25Labeling · Supplement 7 · standardAP
2021-07-21Labeling · Supplement 3 · standardAP
2021-07-21Labeling · Supplement 2 · standardAP
2007-03-30OriginalAP
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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