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ANDA216529

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2025-06-23

Drug application

FDA Application #

ANDA216529

Application type

Abbreviated New Drug Application (Generic)

Brand name

—

Generic name

—

Active ingredients

—

Dosage form

—

Route

—

Marketing status

—

Sponsor

ALKEM LABS LTD

First approval

2025-06-23

Source

Authoritative

Drugs@FDA application overview

Machine

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