← FDA DRUG APPROVALS

FDA ANDA · ANDA209779

NITROGLYCERIN

Sponsor: RUBICON RESEARCH

APPLICATION
ANDA209779
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-03
LATEST ACTION
2024-02-20
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NITROGLYCERINPrescription
NITROGLYCERIN 0.6MG · TABLET · SUBLINGUAL
NITROGLYCERINPrescription
NITROGLYCERIN 0.3MG · TABLET · SUBLINGUAL
NITROGLYCERINPrescription
NITROGLYCERIN 0.4MG · TABLET · SUBLINGUAL

Approval history

2024-02-20Labeling · Supplement 3 · standardAP
2021-05-03UNKNOWN · Original · standardAP
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 →