← FDA Drug Approvals (Drugs@FDA)

LORATADINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2019-12-23

Drug application

FDA Application #

ANDA210722

Application type

Abbreviated New Drug Application (Generic)

Brand name

LORATADINE

Generic name

LORATADINE

Active ingredients

LORATADINE

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

GRANULES

Manufacturer

GRANULES USA, INC.

First approval

2019-12-23

Source

Authoritative

Drugs@FDA application overview

Machine

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