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DICYCLOMINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2020-05-22

Drug application

FDA Application #

ANDA212286

Application type

Abbreviated New Drug Application (Generic)

Brand name

DICYCLOMINE HYDROCHLORIDE

Generic name

DICYCLOMINE HYDROCHLORIDE

Active ingredients

DICYCLOMINE HYDROCHLORIDE

Dosage form

SYRUP

Route

ORAL

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2020-05-22

Source

Authoritative

Drugs@FDA application overview

Machine

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