APPLICATION
ANDA075520
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-08
LATEST ACTION
2020-04-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NORTRIPTYLINE HYDROCHLORIDEPrescription
NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
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
Approval history
2020-04-16Labeling · Supplement 8 · standardAP
2015-04-13Labeling · Supplement 6 · standardAP
2015-04-13Labeling · Supplement 4 · standardAP
2009-02-19Labeling · Supplement 3AP
2007-08-03Labeling · Supplement 2AP
2005-07-20Labeling · Supplement 1AP
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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