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FDA NDA · NDA021359

RECTIV

nitroglycerin

Sponsor: ABBVIE

APPLICATION
NDA021359
TYPE
NDA
ORIGINAL APPROVAL
2011-06-21
LATEST ACTION
2024-07-23
ROUTE
RECTAL, INTRA-ANAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

RECTIV · ReferenceDiscontinued
NITROGLYCERIN 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · INTRA-ANAL

Approval history

2024-07-23Labeling · Supplement 5 · standard — Letter ↗AP
2011-06-21Type 3 - New Dosage Form · Original · priority — Label ↗AP
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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