← FDA Drug Approvals (Drugs@FDA)

LORATADINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MARKSANS PHARMA · Approved 2024-11-21

Drug application

FDA Application #

ANDA219223

Application type

Abbreviated New Drug Application (Generic)

Brand name

LORATADINE

Generic name

LORATADINE TABLETS USP, 10 MG

Active ingredients

LORATADINE

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

MARKSANS PHARMA

Manufacturer

TIME CAP LABORATORIES, INC.

First approval

2024-11-21

Source

Authoritative

Drugs@FDA application overview

Machine

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