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FDA NDA · NDA018861

BETAMETHASONE VALERATE

Sponsor: FOUGERA

APPLICATION
NDA018861
TYPE
NDA
ORIGINAL APPROVAL
1983-08-31
LATEST ACTION
1997-12-04
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

BETAMETHASONE VALERATE · ReferencePrescription
BETAMETHASONE VALERATE EQ 0.1% BASE · CREAM · TOPICAL

Approval history

1997-12-04Manufacturing (CMC) · Supplement 9AP
1996-12-12Labeling · Supplement 8AP
1996-03-07Manufacturing (CMC) · Supplement 7AP
1988-10-20Manufacturing (CMC) · Supplement 5AP
1988-10-20Manufacturing (CMC) · Supplement 4AP
1988-09-14Labeling · Supplement 6AP
1988-09-14Labeling · Supplement 23AP
1987-04-23Manufacturing (CMC) · Supplement 3AP
1987-04-23Manufacturing (CMC) · Supplement 2AP
1983-08-31OriginalAP
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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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