← FDA DRUG APPROVALS

FDA ANDA · ANDA207582

PERPHENAZINE

Sponsor: WATSON LABS INC

APPLICATION
ANDA207582
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-17
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PERPHENAZINEPrescription
PERPHENAZINE 16MG · TABLET · ORAL
PERPHENAZINEPrescription
PERPHENAZINE 4MG · TABLET · ORAL
PERPHENAZINEPrescription
PERPHENAZINE 8MG · TABLET · ORAL
PERPHENAZINEPrescription
PERPHENAZINE 2MG · TABLET · ORAL

Approval history

2025-01-22Labeling · Supplement 4 · standardAP
2016-10-17UNKNOWN · 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →