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FDA NDA · NDA021134

NITROSTAT

nitroglycerin

Sponsor: VIATRIS

APPLICATION
NDA021134
TYPE
NDA
ORIGINAL APPROVAL
2000-05-01
LATEST ACTION
2018-01-24
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NITROSTAT · ReferencePrescription
NITROGLYCERIN 0.6MG · TABLET · SUBLINGUAL
NITROSTAT · ReferencePrescription
NITROGLYCERIN 0.3MG · TABLET · SUBLINGUAL
NITROSTAT · ReferencePrescription
NITROGLYCERIN 0.4MG · TABLET · SUBLINGUAL

Approval history

2018-01-24Labeling · Supplement 10 · standard — Letter ↗AP
2017-01-31Labeling · Supplement 9 · standard — Letter ↗AP
2016-08-29Labeling · Supplement 8 · standard — Label ↗AP
2014-03-07Labeling · Supplement 7 · standard — Label ↗AP
2011-07-21Labeling · Supplement 5 · unknown — Label ↗AP
2010-07-12Labeling · Supplement 4 · unknown — Letter ↗AP
2000-05-01Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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