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FDA ANDA · ANDA074234

NORTRIPTYLINE HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA074234
TYPE
ANDA
ORIGINAL APPROVAL
1993-07-26
LATEST ACTION
2007-10-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

NORTRIPTYLINE HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL

Approval history

2007-10-19Labeling · Supplement 14AP
2007-07-02Labeling · Supplement 13AP
2006-04-05Labeling · Supplement 12AP
2002-07-24Manufacturing (CMC) · Supplement 9AP
2002-05-23Labeling · Supplement 10AP
1999-03-12Manufacturing (CMC) · Supplement 8AP
1999-03-12Manufacturing (CMC) · Supplement 7AP
1998-04-20Labeling · Supplement 6AP
1998-04-20Manufacturing (CMC) · Supplement 5AP
1998-04-20Manufacturing (CMC) · Supplement 3AP
1998-02-05Manufacturing (CMC) · Supplement 4AP
1997-02-18Labeling · Supplement 2AP
1995-06-28Labeling · Supplement 1AP
1993-07-26OriginalAP
VIEW ON DRUGS@FDA ↗

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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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