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KETOCONAZOLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2024-09-16

Drug application

FDA Application #

ANDA218498

Application type

Abbreviated New Drug Application (Generic)

Brand name

KETOCONAZOLE

Generic name

KETOCONAZOLE

Active ingredients

KETOCONAZOLE

Dosage form

SHAMPOO

Route

TOPICAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2024-09-16

Source

Authoritative

Drugs@FDA application overview

Machine

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