APPLICATION
NDA014685
TYPE
NDA
ORIGINAL APPROVAL
1964-11-06
LATEST ACTION
2007-07-30
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
AVENTYL · ReferenceDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL
Approval history
2000-08-23Labeling · Supplement 21 · standardAP
2000-08-23Labeling · Supplement 24 · standardAP
1998-05-29Manufacturing (CMC) · Supplement 23 · standardAP
1998-04-24Manufacturing (CMC) · Supplement 22 · standardAP
1996-07-08Labeling · Supplement 20 · standardAP
1996-07-08Labeling · Supplement 19 · standardAP
1993-05-10Labeling · Supplement 17 · standardAP
1993-05-10Labeling · Supplement 18 · standardAP
1993-05-10Labeling · Supplement 16 · standardAP
1990-06-20Labeling · Supplement 14 · standardAP
1990-06-20Labeling · Supplement 15 · standardAP
1990-06-20Labeling · Supplement 11 · standardAP
1989-02-16Manufacturing (CMC) · Supplement 13 · standardAP
1987-01-09Labeling · Supplement 12 · standardAP
1985-10-25Labeling · Supplement 10 · standardAP
1984-10-05Labeling · Supplement 9 · standardAP
1984-05-24Manufacturing (CMC) · Supplement 8 · standardAP
1984-02-27Labeling · Supplement 7 · 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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