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FDA NDA · NDA012486

TARACTAN

Sponsor: ROCHE

APPLICATION
NDA012486
TYPE
NDA
ORIGINAL APPROVAL
1962-05-07
LATEST ACTION
1997-01-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TARACTANDiscontinued
CHLORPROTHIXENE 100MG · TABLET · ORAL
TARACTANDiscontinued
CHLORPROTHIXENE 25MG · TABLET · ORAL
TARACTANDiscontinued
CHLORPROTHIXENE 10MG · TABLET · ORAL
TARACTANDiscontinued
CHLORPROTHIXENE 50MG · TABLET · ORAL

Approval history

1997-01-09Labeling · Supplement 40AP
1997-01-09Labeling · Supplement 12AP
1997-01-09Labeling · Supplement 49AP
1997-01-09Labeling · Supplement 47AP
1997-01-09Labeling · Supplement 31AP
1997-01-09Labeling · Supplement 48AP
1997-01-09Labeling · Supplement 46AP
1997-01-09Labeling · Supplement 44AP
1997-01-09Labeling · Supplement 36AP
1981-01-29Labeling · Supplement 45AP
1974-06-16Labeling · Supplement 26AP
1962-05-07Type 1 - New Molecular Entity · Original · standardAP
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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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