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FDA ANDA · ANDA074054

NORTRIPTYLINE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA074054
TYPE
ANDA
ORIGINAL APPROVAL
1992-12-31
LATEST ACTION
2002-02-08
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

2002-02-08Labeling · Supplement 15AP
2001-11-06Manufacturing (CMC) · Supplement 14AP
2001-08-03Manufacturing (CMC) · Supplement 13AP
1999-06-09Manufacturing (CMC) · Supplement 10AP
1999-05-05Manufacturing (CMC) · Supplement 11AP
1999-04-05Labeling · Supplement 8AP
1999-04-05Manufacturing (CMC) · Supplement 7AP
1999-03-12Manufacturing (CMC) · Supplement 9AP
1997-12-12Manufacturing (CMC) · Supplement 5AP
1997-09-29Labeling · Supplement 6AP
1996-07-31Manufacturing (CMC) · Supplement 4AP
1995-04-05Labeling · Supplement 3AP
1993-09-22Manufacturing (CMC) · Supplement 1AP
1993-08-24Labeling · Supplement 2AP
1992-12-31OriginalAP
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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