← FDA DRUG APPROVALS

FDA ANDA · ANDA075100

BROMOCRIPTINE MESYLATE

Sponsor: LEK PHARM

APPLICATION
ANDA075100
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-10
LATEST ACTION
1998-12-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

BROMOCRIPTINE MESYLATEDiscontinued
BROMOCRIPTINE MESYLATE EQ 5MG BASE · CAPSULE · ORAL

Approval history

1998-12-10OriginalReviewAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →