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FDA ANDA · ANDA077963

GRANISETRON HYDROCHLORIDE

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA077963
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-03
LATEST ACTION
2014-09-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

GRANISETRON HYDROCHLORIDEDiscontinued
GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) · INJECTABLE · INJECTION

Approval history

2014-09-18Labeling · Supplement 16 · standard — Letter ↗AP
2013-05-30Labeling · Supplement 12 · standardAP
2013-05-30Labeling · Supplement 13 · standardAP
2012-04-11Labeling · Supplement 10 — Label ↗AP
2008-01-03OriginalAP
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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