← FDA DRUG APPROVALS

FDA ANDA · ANDA079124

LAMIVUDINE AND ZIDOVUDINE

Sponsor: HETERO LABS LTD III

APPLICATION
ANDA079124
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-17
LATEST ACTION
2024-09-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LAMIVUDINE AND ZIDOVUDINEPrescription
LAMIVUDINE 150MG, ZIDOVUDINE 300MG · TABLET · ORAL

Approval history

2024-09-19Labeling · Supplement 14 · standardAP
2024-09-19Labeling · Supplement 10 · standardAP
2023-04-19Labeling · Supplement 20 · standardAP
2015-09-17OriginalLetterAP
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 →