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FDA ANDA · ANDA074171

HYDROCORTISONE

Sponsor: TEVA PHARMS

APPLICATION
ANDA074171
TYPE
ANDA
ORIGINAL APPROVAL
1994-05-27
LATEST ACTION
2008-06-17
ROUTE
RECTAL
DOSAGE FORM
ENEMA
MARKETING STATUS
Discontinued

Products

HYDROCORTISONEDiscontinued
HYDROCORTISONE 100MG/60ML · ENEMA · RECTAL

Approval history

2008-06-17Labeling · Supplement 23AP
2002-07-09Manufacturing (CMC) · Supplement 15AP
2002-01-23Manufacturing (CMC) · Supplement 10AP
2002-01-04Manufacturing (CMC) · Supplement 9AP
2002-01-04Manufacturing (CMC) · Supplement 11AP
2001-10-31Manufacturing (CMC) · Supplement 13AP
2001-10-31Manufacturing (CMC) · Supplement 14AP
2001-10-31Manufacturing (CMC) · Supplement 12AP
2001-02-26Manufacturing (CMC) · Supplement 8AP
2000-02-15Manufacturing (CMC) · Supplement 6AP
2000-02-15Manufacturing (CMC) · Supplement 7AP
1999-03-23Manufacturing (CMC) · Supplement 4AP
1998-06-25Manufacturing (CMC) · Supplement 3AP
1996-05-31Manufacturing (CMC) · Supplement 2AP
1995-11-20Manufacturing (CMC) · Supplement 1AP
1994-05-27OriginalAP
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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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