APPLICATION
NDA012704
TYPE
NDA
ORIGINAL APPROVAL
1961-04-11
LATEST ACTION
2003-07-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ELAVILDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
2000-04-05Labeling · Supplement 39 · standardAP
2000-04-05Labeling · Supplement 41 · standardAP
2000-04-05Labeling · Supplement 44 · standardAP
2000-04-05Labeling · Supplement 42 · standardAP
2000-04-05Labeling · Supplement 40 · standardAP
1998-12-24Manufacturing (CMC) · Supplement 43 · standardAP
1995-10-02Manufacturing (CMC) · Supplement 26 · standardAP
1991-06-24Labeling · Supplement 35 · standardAP
1991-06-24Labeling · Supplement 33 · standardAP
1989-07-28Manufacturing (CMC) · Supplement 36 · standardAP
1988-12-12Manufacturing (CMC) · Supplement 34 · standardAP
1986-07-10Labeling · Supplement 32 · standardAP
1985-09-20Labeling · Supplement 31 · standardAP
1984-05-21Labeling · Supplement 28 · standardAP
1983-03-15Labeling · Supplement 30 · standardAP
1981-06-25Manufacturing (CMC) · Supplement 25 · standardAP
1981-03-23Labeling · Supplement 24 · standardAP
1981-03-09Manufacturing (CMC) · Supplement 13 · standardAP
1981-03-02Manufacturing (CMC) · Supplement 17 · standardAP
1981-03-02Manufacturing (CMC) · Supplement 21 · standardAP
1980-09-03Labeling · Supplement 23 · standardAP
1980-06-23Labeling · Supplement 22 · standardAP
1980-03-04Labeling · Supplement 19 · 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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