APPLICATION
ANDA075042
TYPE
ANDA
ORIGINAL APPROVAL
1998-08-25
LATEST ACTION
2003-08-08
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
HYDROCORTISONE VALERATEPrescription
HYDROCORTISONE VALERATE 0.2% · CREAM · TOPICAL
Approval history
2003-08-08Labeling · Supplement 6AP
2002-07-15Manufacturing (CMC) · Supplement 4AP
1999-09-16Manufacturing (CMC) · Supplement 3AP
1999-02-11Manufacturing (CMC) · Supplement 2AP
1998-12-21Manufacturing (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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