APPLICATION
ANDA075172
TYPE
ANDA
ORIGINAL APPROVAL
1999-12-03
LATEST ACTION
2008-10-23
ROUTE
RECTAL
DOSAGE FORM
ENEMA
MARKETING STATUS
Prescription
Products
COLOCORTPrescription
HYDROCORTISONE 100MG/60ML · ENEMA · RECTAL
Approval history
2008-10-23Labeling · Supplement 12AP
2001-07-27Manufacturing (CMC) · Supplement 2AP
2000-05-08Manufacturing (CMC) · Supplement 1AP
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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