← FDA DRUG APPROVALS
FDA ANDA · ANDA216355
PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (ALBUMIN-BOUND)
paclitaxel
Sponsor: SHUANGCHENG
APPLICATION
ANDA216355
TYPE
ANDA
ORIGINAL APPROVAL
2025-05-15
LATEST ACTION
2025-05-15
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
PACLITAXELPrescription
PACLITAXEL 100MG/VIAL · POWDER · INTRAVENOUS
Approval history
2025-05-15UNKNOWN · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.