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
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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