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FDA ANDA · ANDA087795

HYDROCORTISONE

Sponsor: ACTAVIS MID ATLANTIC

APPLICATION
ANDA087795
TYPE
ANDA
ORIGINAL APPROVAL
1983-05-03
LATEST ACTION
2001-04-26
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

HYDROCORTISONEPrescription
HYDROCORTISONE 1% · CREAM · TOPICAL

Approval history

2001-04-26Manufacturing (CMC) · Supplement 22AP
2000-12-27Manufacturing (CMC) · Supplement 21AP
1998-12-21Manufacturing (CMC) · Supplement 20AP
1997-05-13Manufacturing (CMC) · Supplement 19AP
1996-06-28Manufacturing (CMC) · Supplement 18AP
1996-02-07Manufacturing (CMC) · Supplement 17AP
1995-10-18Manufacturing (CMC) · Supplement 11AP
1995-10-18Manufacturing (CMC) · Supplement 16AP
1995-10-18Manufacturing (CMC) · Supplement 14AP
1995-10-18Manufacturing (CMC) · Supplement 12AP
1995-10-18Manufacturing (CMC) · Supplement 10AP
1995-10-18Manufacturing (CMC) · Supplement 15AP
1995-10-18Manufacturing (CMC) · Supplement 13AP
1991-04-15Labeling · Supplement 9AP
1989-07-26Manufacturing (CMC) · Supplement 8AP
1988-05-13Manufacturing (CMC) · Supplement 5AP
1988-05-12Manufacturing (CMC) · Supplement 7AP
1986-06-12Manufacturing (CMC) · Supplement 3AP
1986-06-12Manufacturing (CMC) · Supplement 2AP
1983-05-03OriginalAP
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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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