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FDA ANDA · ANDA086008

ALPHADERM

Sponsor: BIOGLAN

APPLICATION
ANDA086008
TYPE
ANDA
ORIGINAL APPROVAL
1978-01-20
LATEST ACTION
1987-10-19
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

ALPHADERM · ReferenceDiscontinued
HYDROCORTISONE 1%, UREA 10% · CREAM · TOPICAL

Approval history

1987-10-19Manufacturing (CMC) · Supplement 14AP
1987-10-19Manufacturing (CMC) · Supplement 13AP
1983-06-01Manufacturing (CMC) · Supplement 10AP
1982-05-18Manufacturing (CMC) · Supplement 8AP
1978-01-20OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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