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FDA ANDA · ANDA206389

BETAMETHASONE DIPROPIONATE

Sponsor: ENCUBE

APPLICATION
ANDA206389
TYPE
ANDA
ORIGINAL APPROVAL
2018-02-13
LATEST ACTION
2020-06-23
ROUTE
TOPICAL
DOSAGE FORM
LOTION, AUGMENTED
MARKETING STATUS
Prescription

Products

BETAMETHASONE DIPROPIONATEPrescription
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE · LOTION, AUGMENTED · TOPICAL

Approval history

2020-06-23Labeling · Supplement 2 · standardAP
2020-06-23Labeling · Supplement 1 · standardAP
2018-02-13UNKNOWN · Original · standardAP
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