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FLUOCINOLONE ACETONIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ENCUBE ETHICALS · Approved 2019-02-13

Drug application

FDA Application #

ANDA209913

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUOCINOLONE ACETONIDE

Generic name

FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%

Active ingredients

FLUOCINOLONE ACETONIDE

Dosage form

SOLUTION

Route

TOPICAL

Marketing status

Prescription

Sponsor

ENCUBE ETHICALS

Manufacturer

Encube Ethicals, Inc.

First approval

2019-02-13

Source

Authoritative

Drugs@FDA application overview

Machine

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