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DAPSONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ENCUBE · Approved 2023-10-13

Drug application

FDA Application #

ANDA212383

Application type

Abbreviated New Drug Application (Generic)

Brand name

DAPSONE

Generic name

DAPSONE GEL, 5%

Active ingredients

DAPSONE

Dosage form

GEL

Route

TOPICAL

Marketing status

Prescription

Sponsor

ENCUBE

Manufacturer

Encube Ethicals, Inc.

First approval

2023-10-13

Source

Authoritative

Drugs@FDA application overview

Machine

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