← FDA DRUG APPROVALS

FDA ANDA · ANDA205661

METHENAMINE HIPPURATE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA205661
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-05
LATEST ACTION
2023-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METHENAMINE HIPPURATEPrescription
METHENAMINE HIPPURATE 1GM · TABLET · ORAL

Approval history

2023-05-15Labeling · Supplement 1 · standardAP
2023-05-15Labeling · Supplement 3 · standardAP
2016-07-05UNKNOWN · Original · standardAP
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 →