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LOTEPREDNOL ETABONATE AND TOBRAMYCIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2025-12-10

Drug application

FDA Application #

ANDA217597

Application type

Abbreviated New Drug Application (Generic)

Brand name

LOTEPREDNOL ETABONATE AND TOBRAMYCIN

Generic name

LOTEPREDNOL ETABONATE AND TOBRAMYCIN

Active ingredients

LOTEPREDNOL ETABONATE; TOBRAMYCIN

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

ALEMBIC

Manufacturer

Alembic Pharmaceuticals Inc.

First approval

2025-12-10

Source

Authoritative

Drugs@FDA application overview

Machine

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