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FDA NDA · NDA208313

INFUGEM

Sponsor: SUN PHARM

APPLICATION
NDA208313
TYPE
NDA
ORIGINAL APPROVAL
2018-07-16
LATEST ACTION
2024-09-24
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
INFUGEM · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-09-24Labeling · Supplement 7 · standard — Letter ↗AP
2020-01-08Labeling · Supplement 2 · standard — Letter ↗AP
2018-07-16Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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