APPLICATION
ANDA212512
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-13
LATEST ACTION
2022-05-10
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
NEOSTIGMINE METHYLSULFATEPrescription
NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) · SOLUTION · INTRAVENOUS
NEOSTIGMINE METHYLSULFATEPrescription
NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2022-05-10Labeling · Supplement 1 · standardAP
2019-05-13UNKNOWN · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.