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FDA NDA · NDA020885

PAXIL

Sponsor: APOTEX

APPLICATION
NDA020885
TYPE
NDA
ORIGINAL APPROVAL
1998-10-09
LATEST ACTION
2001-04-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PAXIL · ReferenceDiscontinued
PAROXETINE HYDROCHLORIDE EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
PAXIL · ReferenceDiscontinued
PAROXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
PAXIL · ReferenceDiscontinued
PAROXETINE HYDROCHLORIDE EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
PAXIL · ReferenceDiscontinued
PAROXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2001-04-30Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
2001-04-30Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
2000-09-21Manufacturing (CMC) · Supplement 1 · standardAP
2000-07-18Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1998-10-09Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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