← FDA DRUG APPROVALS
FDA ANDA · ANDA212629
PREDNISONE TABLETS, USP, 5 MG
prednisone
Sponsor: POINTVIEW HLDINGS
APPLICATION
ANDA212629
TYPE
ANDA
ORIGINAL APPROVAL
2023-12-05
LATEST ACTION
2024-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISONEPrescription
PREDNISONE 10MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 20MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 5MG · TABLET · ORAL
Approval history
2024-06-07Labeling · Supplement 1 · standardAP
2023-12-05UNKNOWN · Supplement 3 · standardAP
2023-12-05UNKNOWN · Original · standardAP
2023-12-05UNKNOWN · Supplement 2 · 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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