EXTINA

Product NDC

40076-051

11-digit product format

400760051

Labeler code

40076

Product ID

40076-051_1428eeb0-a875-4b64-bd8e-b24eba0189d5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ketoconazole

Dosage form

AEROSOL, FOAM

Route

TOPICAL

Labeler

Prestium Pharma, Inc.

Application

NDA021738

Marketing category

NDA

Marketing start

2014-01-10

Marketing end

2019-05-31

Substance

KETOCONAZOLE

Active strength

20 mg/g

Pharmacologic classes

Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record