← FDA DRUG APPROVALS

FDA NDA · NDA022371

ASTEPRO

Sponsor: MEDA PHARMS

APPLICATION
NDA022371
TYPE
NDA
ORIGINAL APPROVAL
2009-08-31
LATEST ACTION
2009-08-31
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

ASTEPROPrescription
AZELASTINE HYDROCHRLORIDE 0.15% · SPRAY, METERED · NASAL
ASTEPROPrescription
AZELASTINE HYDROCHRLORIDE 0.1% · SPRAY, METERED · NASAL

Approval history

2009-08-31Type 6 - New Indication (no longer used) · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →