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ENALAPRIL MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2022-03-30

Drug application

FDA Application #

ANDA213714

Application type

Abbreviated New Drug Application (Generic)

Brand name

ENALAPRIL MALEATE

Generic name

ENALAPRIL MALEATE ORAL SOLUTION

Active ingredients

ENALAPRIL MALEATE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

Manufacturer

Ascend Laboratories, LLC

First approval

2022-03-30

Source

Authoritative

Drugs@FDA application overview

Machine

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