APPLICATION
ANDA089081
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-04
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PRELONEPrescription
PREDNISOLONE 15MG/5ML · SOLUTION · ORAL
Approval history
2024-06-05Labeling · Supplement 40 · standardAP
2002-12-09Manufacturing (CMC) · Supplement 23AP
2002-09-11Labeling · Supplement 21AP
2002-09-11Labeling · Supplement 22AP
1998-08-05Labeling · Supplement 20AP
1998-06-29Manufacturing (CMC) · Supplement 19AP
1998-05-15Labeling · Supplement 18AP
1997-07-28Manufacturing (CMC) · Supplement 17AP
1994-05-12Labeling · Supplement 15AP
1994-05-10Manufacturing (CMC) · Supplement 16AP
1993-10-15Manufacturing (CMC) · Supplement 14AP
1992-09-03Manufacturing (CMC) · Supplement 11AP
1992-09-03Manufacturing (CMC) · Supplement 12AP
1992-09-03Labeling · Supplement 10AP
1992-07-06Labeling · Supplement 13AP
1991-05-10Manufacturing (CMC) · Supplement 9AP
1988-01-28Manufacturing (CMC) · Supplement 8AP
1988-01-28Manufacturing (CMC) · Supplement 6AP
1988-01-28Manufacturing (CMC) · Supplement 7AP
1987-03-24Manufacturing (CMC) · Supplement 4AP
1987-03-24Manufacturing (CMC) · Supplement 5AP
1986-05-15Manufacturing (CMC) · Supplement 3AP
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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