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FDA NDA · NDA018705

NITROGLYCERIN

Sponsor: POHL BOSKAMP

APPLICATION
NDA018705
TYPE
NDA
ORIGINAL APPROVAL
1985-10-31
LATEST ACTION
2018-07-30
ROUTE
ORAL, SUBLINGUAL
DOSAGE FORM
AEROSOL, SPRAY, METERED
MARKETING STATUS
Discontinued, Prescription

Products

NITROLINGUALDiscontinued
NITROGLYCERIN 0.4MG/SPRAY · AEROSOL · SUBLINGUAL
NITROLINGUAL PUMPSPRAY · ReferencePrescription
NITROGLYCERIN 0.4MG/SPRAY · SPRAY, METERED · SUBLINGUAL

Approval history

2018-07-30Labeling · Supplement 25 · standard — Letter ↗AP
2016-09-02Labeling · Supplement 21 · standardAP
2016-04-21Manufacturing (CMC) · Supplement 20 · standardAP
2015-01-23Labeling · Supplement 19 · standard — Letter ↗AP
2008-10-01Manufacturing (CMC) · Supplement 17 — Label ↗AP
2006-09-28Labeling · Supplement 16 · standard — Letter ↗AP
2006-02-13Labeling · Supplement 15 · standard — Letter ↗AP
2004-09-02Labeling · Supplement 13 · standard — Letter ↗AP
2002-11-05Manufacturing (CMC) · Supplement 12 · standard — Letter ↗AP
1999-11-04Manufacturing (CMC) · Supplement 10 · standardAP
1999-11-04Manufacturing (CMC) · Supplement 9 · standardAP
1999-01-13Labeling · Supplement 8 · standardAP
1998-04-24Labeling · Supplement 7 · standardAP
1997-01-10Efficacy · Supplement 6 · standardAP
1995-01-11Labeling · Supplement 5 · standardAP
1990-03-02Manufacturing (CMC) · Supplement 4 · standardAP
1989-11-13Manufacturing (CMC) · Supplement 3 · standardAP
1988-12-02Labeling · Supplement 2AP
1986-04-23Labeling · Supplement 1AP
1985-10-31Type 3 - New Dosage Form · Original · standardAP
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