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FDA ANDA · ANDA076037

NEFAZODONE HYDROCHLORIDE

Sponsor: TEVA

APPLICATION
ANDA076037
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-16
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NEFAZODONE HYDROCHLORIDEPrescription
NEFAZODONE HYDROCHLORIDE 200MG · TABLET · ORAL
NEFAZODONE HYDROCHLORIDEPrescription
NEFAZODONE HYDROCHLORIDE 100MG · TABLET · ORAL
NEFAZODONE HYDROCHLORIDEPrescription
NEFAZODONE HYDROCHLORIDE 250MG · TABLET · ORAL
NEFAZODONE HYDROCHLORIDEPrescription
NEFAZODONE HYDROCHLORIDE 150MG · TABLET · ORAL
NEFAZODONE HYDROCHLORIDEPrescription
NEFAZODONE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2025-06-24Labeling · Supplement 18 · standardAP
2025-06-16Labeling · Supplement 17 · standardAP
2014-07-17Labeling · Supplement 11 · standard — Label ↗AP
2011-01-20Manufacturing (CMC) · Supplement 10AP
2011-01-13Manufacturing (CMC) · Supplement 9AP
2007-10-29Labeling · Supplement 6AP
2007-10-29Labeling · Supplement 4AP
2005-10-25Labeling · Supplement 2AP
2005-02-18Labeling · Supplement 1AP
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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