← FDA DRUG APPROVALS

FDA NDA · NDA020145

NITROGLYCERIN TRANSDERMAL INFUSION SYSTEM

nitroglycerin

Sponsor: USPHARMA

APPLICATION
NDA020145
TYPE
NDA
ORIGINAL APPROVAL
1985-12-10
LATEST ACTION
2016-01-08
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

NITRO-DUR · ReferencePrescription
NITROGLYCERIN 0.6MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NITRO-DUR · ReferencePrescription
NITROGLYCERIN 0.3MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NITRO-DUR · ReferencePrescription
NITROGLYCERIN 0.1MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NITRO-DUR · ReferencePrescription
NITROGLYCERIN 0.8MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NITRO-DUR · ReferencePrescription
NITROGLYCERIN 0.4MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NITRO-DUR · ReferencePrescription
NITROGLYCERIN 0.2MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2016-01-08Manufacturing (CMC) · Supplement 28AP
2014-10-02Labeling · Supplement 27 · standard — Letter ↗AP
2005-04-05Labeling · Supplement 21 · standard — Letter ↗AP
2004-06-24Labeling · Supplement 15 · standard — Letter ↗AP
2002-10-18Manufacturing (CMC) · Supplement 16 — Letter ↗AP
2002-03-07Manufacturing (CMC) · Supplement 14AP
2001-05-31Manufacturing (CMC) · Supplement 13AP
2000-08-23Manufacturing (CMC) · Supplement 12AP
1999-02-17Labeling · Supplement 11 · standardAP
1997-06-04Manufacturing (CMC) · Supplement 10AP
1996-02-07Labeling · Supplement 9 · standardAP
1995-11-08Manufacturing (CMC) · Supplement 8AP
1995-05-23Labeling · Supplement 7 · standard — Review ↗AP
1995-04-14Labeling · Supplement 6 · standard — Review ↗AP
1995-04-04Manufacturing (CMC) · Supplement 4AP
1995-04-04Manufacturing (CMC) · Supplement 1AP
1985-12-10UNKNOWN · Original · unknownAP
VIEW ON DRUGS@FDA ↗

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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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