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FDA ANDA · ANDA206901

NAFTIFINE HYDROCHLORIDE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA206901
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-06
LATEST ACTION
2019-12-03
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

NAFTIFINE HYDROCHLORIDEPrescription
NAFTIFINE HYDROCHLORIDE 2% · CREAM · TOPICAL

Approval history

2019-12-03Labeling · Supplement 1 · standardAP
2019-12-03Labeling · Supplement 2 · standardAP
2016-01-06UNKNOWN · Original · standard — Letter ↗AP
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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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