← FDA Drug Approvals (Drugs@FDA)

ANDA219328

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LIMITED · Approved 2025-12-22

Drug application

FDA Application #

ANDA219328

Application type

Abbreviated New Drug Application (Generic)

Brand name

—

Generic name

—

Active ingredients

—

Dosage form

—

Route

—

Marketing status

—

Sponsor

AUROBINDO PHARMA LIMITED

First approval

2025-12-22

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown