APPLICATION
ANDA208191
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-26
LATEST ACTION
2023-06-06
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
2023-06-06Labeling · Supplement 4 · standardAP
2023-06-06Labeling · Supplement 2 · standardAP
2023-06-06Labeling · Supplement 1 · 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.
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