APPLICATION
NDA012254
TYPE
NDA
ORIGINAL APPROVAL
1961-04-05
LATEST ACTION
1986-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TINDALDiscontinued
ACETOPHENAZINE MALEATE 20MG · TABLET · ORAL
Approval history
1986-08-29Manufacturing (CMC) · Supplement 17 · standardAP
1982-07-02Labeling · Supplement 13 · standardAP
1981-06-18Labeling · Supplement 11 · standardAP
1981-06-18Labeling · Supplement 12 · standardAP
1980-06-20Manufacturing (CMC) · Supplement 10 · standardAP
1961-04-05Type 1 - New Molecular Entity · Original · standardAP
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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