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FDA ANDA · ANDA206391

NITROGLYCERIN

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APPLICATION
ANDA206391
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-19
LATEST ACTION
2018-07-27
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2018-07-27Labeling · Supplement 1 · standardAP
2018-07-27Labeling · Supplement 2 · standardAP
2017-09-19UNKNOWN · Original · standard — Letter ↗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.

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