APPLICATION
ANDA211575
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-15
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISONEPrescription
PREDNISONE 5MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 50MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 10MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 2.5MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 20MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 16 · standardAP
2019-11-15UNKNOWN · 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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