← FDA DRUG APPROVALS

FDA ANDA · ANDA209294

CLOMIPRAMINE HYDROCHLORIDE

clomipramine hydrochloride capsules

Sponsor: LUPIN

APPLICATION
ANDA209294
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-21
LATEST ACTION
2019-08-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CLOMIPRAMINE HYDROCHLORIDEPrescription
CLOMIPRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL
CLOMIPRAMINE HYDROCHLORIDEPrescription
CLOMIPRAMINE HYDROCHLORIDE 75MG · CAPSULE · ORAL
CLOMIPRAMINE HYDROCHLORIDEPrescription
CLOMIPRAMINE HYDROCHLORIDE 25MG · CAPSULE · ORAL

Approval history

2019-08-15Labeling · Supplement 1 · standardAP
2018-11-21UNKNOWN · Original · standardAP
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 →