APPLICATION
ANDA074304
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-31
LATEST ACTION
2020-06-09
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT, AUGMENTED
MARKETING STATUS
Prescription
Products
BETAMETHASONE DIPROPIONATEPrescription
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE · OINTMENT, AUGMENTED · TOPICAL
Approval history
2020-06-09Labeling · Supplement 25 · standardAP
2020-06-09Labeling · Supplement 26 · standardAP
2016-08-05Labeling · Supplement 23 · standardAP
2002-07-31Manufacturing (CMC) · Supplement 13AP
2002-07-31Manufacturing (CMC) · Supplement 11AP
2002-07-31Labeling · Supplement 12AP
2001-05-30Manufacturing (CMC) · Supplement 10AP
2000-12-29Manufacturing (CMC) · Supplement 9AP
2000-12-29Manufacturing (CMC) · Supplement 8AP
1996-06-28Manufacturing (CMC) · Supplement 7AP
1996-06-24Manufacturing (CMC) · Supplement 6AP
1996-05-15Manufacturing (CMC) · Supplement 5AP
1996-05-15Manufacturing (CMC) · Supplement 3AP
1996-05-15Manufacturing (CMC) · Supplement 4AP
1996-05-15Manufacturing (CMC) · Supplement 2AP
1996-03-04Manufacturing (CMC) · Supplement 1AP
1995-08-31OriginalAP
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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