APPLICATION
ANDA073556
TYPE
ANDA
ORIGINAL APPROVAL
1992-03-30
LATEST ACTION
2020-02-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NORTRIPTYLINE HYDROCHLORIDEPrescription
NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEPrescription
NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEPrescription
NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEPrescription
NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
Approval history
2020-02-21Labeling · Supplement 55 · standardAP
2015-07-15Labeling · Supplement 52 · standardAP
2015-07-15Labeling · Supplement 50 · standardAP
2008-02-20Labeling · Supplement 34AP
2007-07-03Labeling · Supplement 32AP
2007-04-12Labeling · Supplement 29AP
2006-11-01Labeling · Supplement 24AP
2005-07-26Labeling · Supplement 22AP
2002-01-04Labeling · Supplement 16AP
2001-04-25Manufacturing (CMC) · Supplement 15AP
1998-08-26Manufacturing (CMC) · Supplement 12AP
1998-08-26Manufacturing (CMC) · Supplement 13AP
1997-02-07Labeling · Supplement 11AP
1995-12-05Labeling · Supplement 10AP
1995-07-11Manufacturing (CMC) · Supplement 8AP
1995-05-25Manufacturing (CMC) · Supplement 7AP
1995-05-25Manufacturing (CMC) · Supplement 9AP
1995-02-16Manufacturing (CMC) · Supplement 5AP
1995-02-16Manufacturing (CMC) · Supplement 6AP
1993-08-31Labeling · Supplement 4AP
1992-03-30OriginalAP
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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