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FDA ANDA · ANDA076493

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA076493
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-28
LATEST ACTION
2015-10-23
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Prescription

Products

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEPrescription
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE, CLOTRIMAZOLE 1% · LOTION · TOPICAL

Approval history

2015-10-23Labeling · Supplement 8 · standardAP
2009-01-29Labeling · Supplement 4AP
2004-07-28OriginalLetterAP
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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