APPLICATION
ANDA074132
TYPE
ANDA
ORIGINAL APPROVAL
1995-03-27
LATEST ACTION
2024-04-24
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 75MG BASE · CAPSULE · ORAL
NORTRIPTYLINE HYDROCHLORIDEPrescription
NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
Approval history
2024-04-24Labeling · Supplement 31 · standardAP
2020-04-15Labeling · Supplement 28 · standardAP
2015-04-13Labeling · Supplement 26 · standardAP
2015-04-13Labeling · Supplement 24 · standardAP
2010-12-30Labeling · Supplement 22AP
2007-10-19Labeling · Supplement 20AP
2007-07-02Labeling · Supplement 19AP
2007-04-11Labeling · Supplement 18AP
2005-07-20Labeling · Supplement 15AP
2002-02-20Labeling · Supplement 10AP
2001-08-30Manufacturing (CMC) · Supplement 9AP
2000-07-07Manufacturing (CMC) · Supplement 8AP
1998-07-21Manufacturing (CMC) · Supplement 6AP
1998-07-21Manufacturing (CMC) · Supplement 7AP
1997-03-27Labeling · Supplement 5AP
1996-01-25Manufacturing (CMC) · Supplement 4AP
1996-01-25Manufacturing (CMC) · Supplement 2AP
1996-01-25Manufacturing (CMC) · Supplement 3AP
1995-09-26Labeling · Supplement 1AP
1995-03-27OriginalAP
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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