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OLOPATADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLAND · Approved 2026-01-06

Drug application

FDA Application #
ANDA213514
Application type
Abbreviated New Drug Application (Generic)
Brand name
OLOPATADINE HYDROCHLORIDE
Generic name
OLOPATADINE HYDROCHLORIDE OPHTHALMIC
Active ingredients
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
Marketing status
Over-the-counter
Sponsor
GLAND
Manufacturer
Dr. Reddy's Laboratories Inc.
First approval
2026-01-06

Source

Authoritative
Drugs@FDA application overview
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