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FDA NDA · NDA019137

BETAMETHASONE DIPROPIONATE

Sponsor: FOUGERA

APPLICATION
NDA019137
TYPE
NDA
ORIGINAL APPROVAL
1984-06-26
LATEST ACTION
2014-09-04
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

BETAMETHASONE DIPROPIONATE · ReferencePrescription
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE · CREAM · TOPICAL

Approval history

2014-09-04Manufacturing (CMC) · Supplement 14AP
1997-12-05Manufacturing (CMC) · Supplement 12AP
1996-03-07Manufacturing (CMC) · Supplement 11AP
1995-08-17Labeling · Supplement 10AP
1988-10-31Manufacturing (CMC) · Supplement 8AP
1988-10-31Manufacturing (CMC) · Supplement 9AP
1988-10-31Manufacturing (CMC) · Supplement 7AP
1987-10-20Manufacturing (CMC) · Supplement 5AP
1987-07-06Manufacturing (CMC) · Supplement 6AP
1986-03-28Manufacturing (CMC) · Supplement 1AP
1986-03-18Manufacturing (CMC) · Supplement 2AP
1984-06-26OriginalAP
VIEW ON DRUGS@FDA ↗

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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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