← FDA DRUG APPROVALS

FDA ANDA · ANDA091364

ZOLEDRONIC ACID

Sponsor: DR REDDYS LABS LTD

APPLICATION
ANDA091364
TYPE
ANDA
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval)

Products

ZOLEDRONIC ACIDNone (Tentative Approval)
ZOLEDRONIC ACID 5MG/100ML · INJECTABLE · INJECTION

Approval history

2011-10-31OriginalTA
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 →