← FDA DRUG APPROVALS

FDA ANDA · ANDA215560

ATENOLOL AND CHLORTHALIDONE

atenolol and chlorthalidone tablet

Sponsor: NOVITIUM PHARMA

APPLICATION
ANDA215560
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-25
LATEST ACTION
2024-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ATENOLOL AND CHLORTHALIDONEPrescription
ATENOLOL 100MG, CHLORTHALIDONE 25MG · TABLET · ORAL
ATENOLOL AND CHLORTHALIDONEPrescription
ATENOLOL 50MG, CHLORTHALIDONE 25MG · TABLET · ORAL

Approval history

2024-09-23Labeling · Supplement 10 · standardAP
2021-10-25UNKNOWN · 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 →