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OLOPATADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS · Approved 2025-02-28

Drug application

FDA Application #
ANDA219557
Application type
Abbreviated New Drug Application (Generic)
Brand name
OLOPATADINE HYDROCHLORIDE
Generic name
OLOPATADINE HYDROCHLORIDE
Active ingredients
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
Marketing status
Over-the-counter
Sponsor
GLENMARK PHARMS
Manufacturer
GLENMARK THERAPEUTICS INC., USA
First approval
2025-02-28

Source

Authoritative
Drugs@FDA application overview
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