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FDA NDA · NDA209604

GEMCITABINE

Sponsor: ACCORD HLTHCARE

APPLICATION
NDA209604
TYPE
NDA
ORIGINAL APPROVAL
2017-08-03
LATEST ACTION
2024-09-24
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

GEMCITABINE HYDROCHLORIDE · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) · SOLUTION · INTRAVENOUS
GEMCITABINE HYDROCHLORIDE · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) · SOLUTION · INTRAVENOUS
GEMCITABINE HYDROCHLORIDE · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) · SOLUTION · INTRAVENOUS
GEMCITABINE HYDROCHLORIDE · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-09-24Labeling · Supplement 11 · standard — Letter ↗AP
2019-06-25Labeling · Supplement 4 · standard — Letter ↗AP
2018-12-18Labeling · Supplement 2 · standard — Label ↗AP
2018-07-30Labeling · Supplement 3 · 901 required — Label ↗AP
2017-08-03Type 5 - New Formulation or New Manufacturer · Original · standard — 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.

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