← FDA Drug Approvals (Drugs@FDA)

STERILE WATER FOR INJECTION

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2023-01-31

Drug application

FDA Application #

ANDA212735

Application type

Abbreviated New Drug Application (Generic)

Brand name

STERILE WATER FOR INJECTION

Generic name

STERILE WATER

Active ingredients

STERILE WATER FOR INJECTION

Dosage form

LIQUID

Route

N/A

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2023-01-31

Source

Authoritative

Drugs@FDA application overview

Machine

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