← FDA DRUG APPROVALS

FDA NDA · NDA018733

TALWIN NX

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA018733
TYPE
NDA
ORIGINAL APPROVAL
1982-12-16
LATEST ACTION
2011-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TALWIN NXDiscontinued
NALOXONE HYDROCHLORIDE EQ 0.5MG BASE, PENTAZOCINE HYDROCHLORIDE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2011-02-24Labeling · Supplement 15 · priority — Letter ↗AP
2008-09-01Labeling · Supplement 14 · priority — Label ↗AP
2003-02-26Labeling · Supplement 12 · priority — Letter ↗AP
1989-01-12Labeling · Supplement 10 · priorityAP
1989-01-12Labeling · Supplement 7 · priorityAP
1988-02-29Manufacturing (CMC) · Supplement 11 · priorityAP
1987-02-02Manufacturing (CMC) · Supplement 9 · priorityAP
1985-10-09Labeling · Supplement 8 · priorityAP
1983-04-05Manufacturing (CMC) · Supplement 6 · priorityAP
1983-04-05Manufacturing (CMC) · Supplement 4 · priorityAP
1983-04-05Manufacturing (CMC) · Supplement 2 · priorityAP
1983-04-05Manufacturing (CMC) · Supplement 5 · priorityAP
1983-04-05Manufacturing (CMC) · Supplement 3 · priorityAP
1983-04-05Manufacturing (CMC) · Supplement 1 · priorityAP
1982-12-16Type 4 - New Combination · Original · priorityAP
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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