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FDA NDA · NDA016904

NAVANE

Sponsor: PFIZER

APPLICATION
NDA016904
TYPE
NDA
ORIGINAL APPROVAL
1971-08-19
LATEST ACTION
2009-07-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

NAVANEDiscontinued
THIOTHIXENE HYDROCHLORIDE EQ 10MG BASE/VIAL · INJECTABLE · INJECTION
NAVANEDiscontinued
THIOTHIXENE HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION

Approval history

2009-07-19Labeling · Supplement 34 · standard — Label ↗AP
2008-04-07Labeling · Supplement 33 · standard — Letter ↗AP
1996-08-02Manufacturing (CMC) · Supplement 31 · standardAP
1996-07-25Manufacturing (CMC) · Supplement 30 · standardAP
1994-07-15Manufacturing (CMC) · Supplement 29 · standardAP
1989-07-19Manufacturing (CMC) · Supplement 27 · standardAP
1987-12-10Manufacturing (CMC) · Supplement 25 · standardAP
1985-08-26Manufacturing (CMC) · Supplement 22 · standardAP
1984-07-10Manufacturing (CMC) · Supplement 17 · standardAP
1984-02-17Manufacturing (CMC) · Supplement 19 · standardAP
1983-12-08Manufacturing (CMC) · Supplement 18 · standardAP
1982-01-18Manufacturing (CMC) · Supplement 13 · standardAP
1982-01-18Labeling · Supplement 14AP
1981-06-02Manufacturing (CMC) · Supplement 10 · standardAP
1980-12-10Labeling · Supplement 11AP
1979-10-12Manufacturing (CMC) · Supplement 8 · standardAP
1979-09-21Manufacturing (CMC) · Supplement 9 · standardAP
1971-08-19Type 2 - New Active Ingredient · Original · standardAP
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