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FDA ANDA · ANDA076129

NEFAZODONE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA076129
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-16
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NEFAZODONE HYDROCHLORIDEDiscontinued
NEFAZODONE HYDROCHLORIDE 200MG · TABLET · ORAL
NEFAZODONE HYDROCHLORIDEDiscontinued
NEFAZODONE HYDROCHLORIDE 100MG · TABLET · ORAL
NEFAZODONE HYDROCHLORIDEDiscontinued
NEFAZODONE HYDROCHLORIDE 250MG · TABLET · ORAL
NEFAZODONE HYDROCHLORIDEDiscontinued
NEFAZODONE HYDROCHLORIDE 150MG · TABLET · ORAL

Approval history

2025-06-24Labeling · Supplement 4 · standardAP
2014-07-18Labeling · Supplement 2 · standardAP
2003-09-16Original — Other Important Information from FDA ↗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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