APPLICATION
NDA014684
TYPE
NDA
ORIGINAL APPROVAL
1964-11-06
LATEST ACTION
2000-08-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
AVENTYL HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
AVENTYL HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
Approval history
2000-08-23Labeling · Supplement 36 · standardAP
2000-08-23Labeling · Supplement 40 · standardAP
1998-06-19Manufacturing (CMC) · Supplement 38 · standardAP
1998-05-29Manufacturing (CMC) · Supplement 39 · standardAP
1998-04-03Manufacturing (CMC) · Supplement 37 · standardAP
1996-07-08Labeling · Supplement 35 · standardAP
1996-07-08Labeling · Supplement 33 · standardAP
1994-06-16Manufacturing (CMC) · Supplement 34 · standardAP
1993-07-14Manufacturing (CMC) · Supplement 32 · standardAP
1993-05-10Labeling · Supplement 28 · standardAP
1993-05-10Labeling · Supplement 29 · standardAP
1993-05-10Labeling · Supplement 31 · standardAP
1992-05-22Manufacturing (CMC) · Supplement 30 · standardAP
1990-06-20Labeling · Supplement 26 · standardAP
1990-06-20Labeling · Supplement 20 · standardAP
1990-06-20Labeling · Supplement 27 · standardAP
1988-04-19Manufacturing (CMC) · Supplement 25 · standardAP
1987-06-15Manufacturing (CMC) · Supplement 22 · standardAP
1987-06-10Manufacturing (CMC) · Supplement 23 · standardAP
1987-04-07Manufacturing (CMC) · Supplement 24 · standardAP
1985-11-06Labeling · Supplement 19 · standardAP
1984-10-05Labeling · Supplement 18 · standardAP
1984-02-27Labeling · Supplement 17 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 16 · standardAP
1981-03-18Manufacturing (CMC) · Supplement 14 · standardAP
1979-12-20Manufacturing (CMC) · Supplement 13 · standardAP
1978-07-07Manufacturing (CMC) · Supplement 12 · standardAP
1977-06-01Manufacturing (CMC) · Supplement 9 · standardAP
1964-11-06Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
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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