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FDA ANDA · ANDA078258

GRANISETRON HYDROCHLORIDE

Sponsor: AMNEAL

APPLICATION
ANDA078258
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-30
LATEST ACTION
2015-06-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

GRANISETRON HYDROCHLORIDEPrescription
GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) · INJECTABLE · INJECTION
GRANISETRON HYDROCHLORIDEPrescription
GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) · INJECTABLE · INJECTION

Approval history

2015-06-13Labeling · Supplement 2 · standardAP
2014-10-17Labeling · Supplement 1 · standardAP
2008-06-30OriginalAP
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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