← FDA DRUG APPROVALS

FDA ANDA · ANDA090462

PROTRIPTYLINE HYDROCHLORIDE

Sponsor: SIGMAPHARM LABS LLC

APPLICATION
ANDA090462
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-03
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PROTRIPTYLINE HYDROCHLORIDEPrescription
PROTRIPTYLINE HYDROCHLORIDE 10MG · TABLET · ORAL
PROTRIPTYLINE HYDROCHLORIDEPrescription
PROTRIPTYLINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2014-07-17Labeling · Supplement 3 · standardAP
2010-05-03OriginalAP
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 →