APPLICATION
ANDA088497
TYPE
ANDA
ORIGINAL APPROVAL
1984-02-21
LATEST ACTION
2002-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLPREDNISOLONEDiscontinued
METHYLPREDNISOLONE 4MG · TABLET · ORAL
Approval history
2002-09-16Labeling · Supplement 43AP
2002-09-16Labeling · Supplement 44AP
2002-07-22Manufacturing (CMC) · Supplement 41AP
2002-07-22Manufacturing (CMC) · Supplement 42AP
2002-06-19Manufacturing (CMC) · Supplement 45AP
2001-08-16Manufacturing (CMC) · Supplement 40AP
1999-02-12Manufacturing (CMC) · Supplement 39AP
1997-06-23Labeling · Supplement 38AP
1995-03-09Labeling · Supplement 37AP
1995-01-20Manufacturing (CMC) · Supplement 25AP
1994-02-04Labeling · Supplement 36AP
1993-05-24Manufacturing (CMC) · Supplement 35AP
1992-11-16Manufacturing (CMC) · Supplement 30AP
1988-10-04Manufacturing (CMC) · Supplement 14AP
1988-10-04Manufacturing (CMC) · Supplement 15AP
1988-07-12Labeling · Supplement 23AP
1988-03-11Labeling · Supplement 22AP
1987-02-12Manufacturing (CMC) · Supplement 18AP
1987-02-12Manufacturing (CMC) · Supplement 19AP
1987-02-12Manufacturing (CMC) · Supplement 17AP
1986-08-08Manufacturing (CMC) · Supplement 12AP
1986-08-08Manufacturing (CMC) · Supplement 13AP
1986-08-08Manufacturing (CMC) · Supplement 11AP
1986-05-15Manufacturing (CMC) · Supplement 4AP
1985-07-17Manufacturing (CMC) · Supplement 6AP
1985-07-17Manufacturing (CMC) · Supplement 7AP
1985-07-17Manufacturing (CMC) · Supplement 5AP
1984-10-01Manufacturing (CMC) · Supplement 2AP
1984-10-01Manufacturing (CMC) · Supplement 1AP
1984-02-21OriginalAP
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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