← FDA DRUG APPROVALS

FDA ANDA · ANDA040836

GLYCOPYRROLATE

Sponsor: HIKMA INTL PHARMS

APPLICATION
ANDA040836
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-05
LATEST ACTION
2023-06-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GLYCOPYRROLATEDiscontinued
GLYCOPYRROLATE 1MG · TABLET · ORAL
GLYCOPYRROLATEDiscontinued
GLYCOPYRROLATE 2MG · TABLET · ORAL

Approval history

2023-06-23Labeling · Supplement 4 · standardAP
2009-03-05OriginalAP
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 →