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FDA ANDA · ANDA077511
SILKA JOCK ITCH
terbinafine hydrochloride
Sponsor: SUN PHARMA CANADA
APPLICATION
ANDA077511
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-02
LATEST ACTION
2019-02-28
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter
Products
TERBINAFINE HYDROCHLORIDEOver-the-counter
TERBINAFINE HYDROCHLORIDE 1% · CREAM · TOPICAL
Approval history
2019-02-28Labeling · Supplement 15 · standardAP
2014-10-22Manufacturing (CMC) · Supplement 5AP
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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