← FDA DRUG APPROVALS

FDA NDA · NDA021304

VALCYTE

valganciclovir

Sponsor: CHEPLAPHARM

APPLICATION
NDA021304
TYPE
NDA
ORIGINAL APPROVAL
2001-03-29
LATEST ACTION
2021-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VALCYTE · ReferencePrescription
VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE · TABLET · ORAL

Approval history

2021-12-23Labeling · Supplement 17 · standard — Letter ↗AP
2020-11-24Labeling · Supplement 16 · standard — Label ↗AP
2020-10-21Labeling · Supplement 15 · standard — Letter ↗AP
2018-08-02Efficacy · Supplement 14 · standard — Letter ↗AP
2017-06-22Labeling · Supplement 12 · standard — Letter ↗AP
2015-04-23Efficacy · Supplement 11 · standard — Letter ↗AP
2013-03-28Labeling · Supplement 10 · standard — Label ↗AP
2010-08-05Efficacy · Supplement 8 · standard — Label ↗AP
2009-08-28Efficacy · Supplement 7 · priority — Letter ↗AP
2006-01-31Labeling · Supplement 4 · standard — Label ↗AP
2003-09-12Efficacy · Supplement 1 · standard — Letter ↗AP
2001-03-29Type 2 - New Active Ingredient · Original · priority — Letter ↗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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