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LORATADINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2003-08-20

Drug application

FDA Application #

ANDA076154

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

MYLAN

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

2003-08-20

Source

Authoritative

Drugs@FDA application overview

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