← FDA DRUG APPROVALS

FDA NDA · NDA210134

BAQSIMI

glucagon

Sponsor: AMPHASTAR PHARMS INC

APPLICATION
NDA210134
TYPE
NDA
ORIGINAL APPROVAL
2019-07-24
LATEST ACTION
2025-03-17
ROUTE
NASAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

BAQSIMI · ReferencePrescription
GLUCAGON 3MG · POWDER · NASAL

Approval history

2025-03-17Efficacy · Supplement 4 · priority — Label ↗AP
2020-10-27Labeling · Supplement 2 · standard — Label ↗AP
2019-07-24Type 3 - New Dosage Form · Original · standard — Label ↗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 →