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OLOPATADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS ISRAEL · Approved 2017-01-31

Drug application

FDA Application #

ANDA202853

Application type

Abbreviated New Drug Application (Generic)

Brand name

OLOPATADINE HYDROCHLORIDE

Generic name

OLOPATADINE HYDROCHLORIDE

Active ingredients

OLOPATADINE HYDROCHLORIDE

Dosage form

SPRAY, METERED

Route

NASAL

Marketing status

Prescription

Sponsor

PADAGIS ISRAEL

Manufacturer

Padagis Israel Pharmaceuticals Ltd

First approval

2017-01-31

Source

Authoritative

Drugs@FDA application overview

Machine

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