APPLICATION
NDA010533
TYPE
NDA
ORIGINAL APPROVAL
1956-07-05
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PBZ-SRDiscontinued
TRIPELENNAMINE HYDROCHLORIDE 50MG · TABLET, EXTENDED RELEASE · ORAL
PBZ-SRDiscontinued
TRIPELENNAMINE HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2007-12-07Labeling · Supplement 10AP
2007-12-07Labeling · Supplement 27AP
2007-12-07Labeling · Supplement 19AP
2007-12-07Labeling · Supplement 17AP
2007-12-07Labeling · Supplement 15AP
2007-12-07Labeling · Supplement 21AP
2007-12-07Labeling · Supplement 8AP
2007-12-07Labeling · Supplement 4AP
2007-12-07Labeling · Supplement 18AP
2007-12-07Labeling · Supplement 20AP
1999-04-23Manufacturing (CMC) · Supplement 33 · standardAP
1998-03-20Efficacy · Supplement 24AP
1992-11-19Manufacturing (CMC) · Supplement 30 · standardAP
1956-07-05Type 5 - New Formulation or New Manufacturer · 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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