NDC 71337-035

KETOCONAZOLE

Ketoconazole

KETOCONAZOLE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Havix Group Inc D-b-a Aavis Pharmaceuticals. The primary component is Ketoconazole.

Product ID71337-035_efe0105c-ddef-4d3b-9be9-f9ed478b0f03
NDC71337-035
Product TypeHuman Prescription Drug
Proprietary NameKETOCONAZOLE
Generic NameKetoconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-11-12
Marketing CategoryANDA / ANDA
Application NumberANDA075912
Labeler NameHavix Group Inc d-b-a Aavis Pharmaceuticals
Substance NameKETOCONAZOLE
Active Ingredient Strength200 mg/1
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71337-035-01

100 TABLET in 1 BOTTLE (71337-035-01)
Marketing Start Date2020-11-13
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "KETOCONAZOLE" or generic name "Ketoconazole"

NDCBrand NameGeneric Name
0093-0900KetoconazoleKetoconazole
0093-3219KetoconazoleKetoconazole
0168-0099ketoconazoleketoconazole
0378-0261Ketoconazoleketoconazole
0713-0671KetoconazoleKetoconazole
10147-0750KETOCONAZOLEketoconazole
16714-955KetoconazoleKetoconazole
21695-554KetoconazoleKetoconazole
21695-555KetoconazoleKetoconazole
21695-556KetoconazoleKetoconazole
21695-562KetoconazoleKetoconazole
21922-025KetoconazoleKetoconazole Cream, 2%
33261-739KetoconazoleKetoconazole
35573-433KETOCONAZOLEketoconazole
43063-036Ketoconazoleketoconazole
43063-882KetoconazoleKetoconazole
45802-465KetoconazoleKetoconazole
45802-532ketoconazoleketoconazole
50090-0719ketoconazoleketoconazole
50090-0720ketoconazoleketoconazole
68071-1614KetoconazoleKetoconazole
68071-1743KetoconazoleKetoconazole
68071-1735KetoconazoleKetoconazole
68071-1709KetoconazoleKetoconazole
68071-4012KetoconazoleKetoconazole
68084-552KetoconazoleKetoconazole
68151-2713KetoconazoleKetoconazole
68258-3998KetoconazoleKetoconazole
68788-9708KetoconazoleKetoconazole
68788-9903KetoconazoleKetoconazole
68788-9117KetoconazoleKetoconazole
68788-9915KetoconazoleKetoconazole
70518-0915KetoconazoleKetoconazole
70518-1637ketoconazoleketoconazole
71205-105KetoconazoleKetoconazole
71085-008KetoconazoleKetoconazole
71335-0439KetoconazoleKetoconazole
50090-1220KetoconazoleKetoconazole
50090-1524KetoconazoleKetoconazole
50090-3207KetoconazoleKetoconazole
50090-1992KetoconazoleKetoconazole
50090-1675KetoconazoleKetoconazole
50090-3288KetoconazoleKetoconazole
50090-3299KetoconazoleKetoconazole
50436-4448ketoconazoleketoconazole
51672-4026KetoconazoleKetoconazole
51672-1298KetoconazoleKetoconazole
53217-015KetoconazoleKetoconazole
53002-8150KetoconazoleKetoconazole
53808-0842KetoconazoleKetoconazole

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.