← FDA DRUG APPROVALS

FDA NDA · NDA209936

ALIQOPA

Sponsor: BAYER HEALTHCARE

APPLICATION
NDA209936
TYPE
NDA
ORIGINAL APPROVAL
2017-09-14
LATEST ACTION
2023-09-07
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

ALIQOPA · ReferenceDiscontinued
COPANLISIB DIHYDROCHLORIDE 60MG/VIAL · POWDER · INTRAVENOUS

Approval history

2023-09-07Labeling · Supplement 12 · standard — Label ↗AP
2023-03-30Labeling · Supplement 11 · standard — Letter ↗AP
2022-02-23Labeling · Supplement 10 · standard — Letter ↗AP
2021-05-17Labeling · Supplement 6 · standardAP
2020-02-12Labeling · Supplement 4 · standard — Label ↗AP
2019-10-28Labeling · Supplement 3 · standard — Label ↗AP
2019-05-24Labeling · Supplement 2 · standard — Label ↗AP
2017-09-14Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →