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FDA NDA · NDA022257

VALCYTE

valganciclovir hydrochloride

Sponsor: CHEPLAPHARM

APPLICATION
NDA022257
TYPE
NDA
ORIGINAL APPROVAL
2009-08-28
LATEST ACTION
2021-12-23
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

VALCYTE · ReferencePrescription
VALGANCICLOVIR HYDROCHLORIDE 50MG/ML · FOR SOLUTION · ORAL

Approval history

2021-12-23Labeling · Supplement 12 · standard — Letter ↗AP
2020-11-24Labeling · Supplement 11 · standard — Label ↗AP
2020-10-21Manufacturing (CMC) · Supplement 10 — Letter ↗AP
2018-08-02Efficacy · Supplement 9 · standard — Letter ↗AP
2017-06-22Labeling · Supplement 7 · standard — Letter ↗AP
2015-07-14Manufacturing (CMC) · Supplement 6 · priorityAP
2015-04-23Efficacy · Supplement 5 · standard — Label ↗AP
2013-03-28Labeling · Supplement 4 · standard — Letter ↗AP
2010-08-05Labeling · Supplement 3 · unknown — Label ↗AP
2009-08-28Type 3 - New Dosage Form · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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