← FDA DRUG APPROVALS

FDA ANDA · ANDA073644

VIVACTIL

Sponsor: CHARTWELL RX

APPLICATION
ANDA073644
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-24
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VIVACTILDiscontinued
PROTRIPTYLINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2014-07-17Labeling · Supplement 23 · standard — Label ↗AP
2007-06-25Labeling · Supplement 17AP
2006-04-05Labeling · Supplement 10AP
2002-07-18Manufacturing (CMC) · Supplement 6AP
2001-08-03Manufacturing (CMC) · Supplement 5AP
2001-04-03Manufacturing (CMC) · Supplement 4AP
2000-09-12Manufacturing (CMC) · Supplement 1AP
2000-07-24Labeling · Supplement 3AP
2000-07-07Manufacturing (CMC) · Supplement 2AP
1995-08-24Original — 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.

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 →