← FDA DRUG APPROVALS

FDA ANDA · ANDA202853

OLOPATADINE HYDROCHLORIDE

Sponsor: PADAGIS ISRAEL

APPLICATION
ANDA202853
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-31
LATEST ACTION
2021-11-16
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

OLOPATADINE HYDROCHLORIDEPrescription
OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2021-11-16Labeling · Supplement 11 · standardAP
2017-01-31UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →