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FDA ANDA · ANDA085084

PREDNISONE

Sponsor: WATSON LABS

APPLICATION
ANDA085084
TYPE
ANDA
ORIGINAL APPROVAL
1976-06-23
LATEST ACTION
1998-03-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PREDNISONEDiscontinued
PREDNISONE 5MG · TABLET · ORAL

Approval history

1998-03-30Manufacturing (CMC) · Supplement 45AP
1998-03-30Manufacturing (CMC) · Supplement 46AP
1998-03-30Manufacturing (CMC) · Supplement 44AP
1994-11-02Labeling · Supplement 43AP
1993-12-23Labeling · Supplement 42AP
1991-02-05Labeling · Supplement 41AP
1988-06-22Manufacturing (CMC) · Supplement 39AP
1988-06-22Manufacturing (CMC) · Supplement 37AP
1988-06-22Manufacturing (CMC) · Supplement 35AP
1988-06-22Manufacturing (CMC) · Supplement 38AP
1988-06-22Manufacturing (CMC) · Supplement 36AP
1988-06-22Manufacturing (CMC) · Supplement 34AP
1988-06-22Manufacturing (CMC) · Supplement 40AP
1986-12-11Manufacturing (CMC) · Supplement 14AP
1984-06-29Manufacturing (CMC) · Supplement 25AP
1982-09-24Manufacturing (CMC) · Supplement 24AP
1982-09-24Manufacturing (CMC) · Supplement 22AP
1981-12-15Manufacturing (CMC) · Supplement 17AP
1981-12-15Manufacturing (CMC) · Supplement 18AP
1981-12-15Manufacturing (CMC) · Supplement 20AP
1976-06-23OriginalAP
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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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