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FDA ANDA · ANDA077297

GRANISETRON HYDROCHLORIDE

Sponsor: DR REDDYS

APPLICATION
ANDA077297
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-30
LATEST ACTION
2014-09-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2014-09-18Labeling · Supplement 16 · standard — Label ↗AP
2013-05-30Labeling · Supplement 12 · standardAP
2013-05-30Labeling · Supplement 13 · standardAP
2012-04-13Labeling · Supplement 10 — Review ↗AP
2008-06-30Original — Letter ↗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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