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FDA NDA · NDA200795

GEMCITABINE

Sponsor: HOSPIRA INC

APPLICATION
NDA200795
TYPE
NDA
ORIGINAL APPROVAL
2011-08-04
LATEST ACTION
2024-05-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

GEMCITABINE HYDROCHLORIDE · ReferencePrescription
GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDE · ReferencePrescription
GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDE · ReferencePrescription
GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) · INJECTABLE · INJECTION

Approval history

2024-05-31Labeling · Supplement 18 · standard — Letter ↗AP
2019-06-21Labeling · Supplement 10 · standard — Letter ↗AP
2018-01-26Labeling · Supplement 8 · standard — Letter ↗AP
2016-04-07Manufacturing (CMC) · Supplement 6 · standardAP
2014-05-08Labeling · Supplement 5 · 901 required — Label ↗AP
2013-11-27Manufacturing (CMC) · Supplement 3 · standardAP
2013-09-05Labeling · Supplement 4 · standard — Label ↗AP
2013-06-20Manufacturing (CMC) · Supplement 2 · standardAP
2012-12-18Manufacturing (CMC) · Supplement 1 · standardAP
2011-08-04Type 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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