APPLICATION
ANDA083778
TYPE
ANDA
ORIGINAL APPROVAL
1976-08-13
LATEST ACTION
1992-08-20
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
PRAMOSONEPrescription
HYDROCORTISONE ACETATE 0.5%, PRAMOXINE HYDROCHLORIDE 1% · CREAM · TOPICAL
Approval history
1992-08-20Manufacturing (CMC) · Supplement 8AP
1991-08-08Labeling · Supplement 7AP
1976-08-13OriginalAP
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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