APPLICATION
ANDA040189
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-31
LATEST ACTION
2007-07-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHYLPREDNISOLONEPrescription
METHYLPREDNISOLONE 16MG · TABLET · ORAL
METHYLPREDNISOLONEPrescription
METHYLPREDNISOLONE 4MG · TABLET · ORAL
METHYLPREDNISOLONEPrescription
METHYLPREDNISOLONE 32MG · TABLET · ORAL
METHYLPREDNISOLONEPrescription
METHYLPREDNISOLONE 8MG · TABLET · ORAL
Approval history
2007-07-19Labeling · Supplement 10AP
2003-07-14Labeling · Supplement 6AP
2002-09-05Labeling · Supplement 5AP
2002-09-05Labeling · Supplement 4AP
1998-03-19Manufacturing (CMC) · Supplement 1AP
1998-03-19Labeling · Supplement 2AP
1997-10-31OriginalAP
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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