Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021304
Company: HOFFMANN LA ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALCYTE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/29/2001 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21304lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21304ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21304_Valcyte.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/2018 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021304Orig1s014,022257Orig1s009ltr.pdf
06/22/2017 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021304Orig1s012,022257Orig1s007ltr.pdf
04/23/2015 SUPPL-11 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021304Orig1s011,022257Orig1s005ltr.pdf
03/28/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021304Orig1s010,022257Orig1s004ltr.pdf
08/05/2010 SUPPL-8 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021304s008,022257s003ltr.pdf
08/28/2009 SUPPL-7 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022257s000_021304s07ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257_021304s007_valcyte_valganciclovir hydrochloride_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257Original-1_021304s007sumr.pdf
01/31/2006 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021304s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021304s004ltr.pdf
09/12/2003 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21304se1-001_valcyte_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21304se1-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021304_S001_VALCYTE.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/02/2018 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf
06/22/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf
06/22/2017 SUPPL-12 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf
04/23/2015 SUPPL-11 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf
03/28/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf
08/05/2010 SUPPL-8 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf
08/28/2009 SUPPL-7 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf
01/31/2006 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021304s004lbl.pdf
09/12/2003 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21304se1-001_valcyte_lbl.pdf
03/29/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21304lbl.pdf

VALCYTE

TABLET;ORAL; EQ 450MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VALCYTE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription Yes AB 021304 HOFFMANN LA ROCHE
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 204750 AUROBINDO PHARMA LTD
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 209672 CIPLA
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 206876 DR REDDYS
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 203511 DR REDDYS LABS LTD
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 200790 ENDO PHARMS INC
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 205166 HETERO LABS LTD V

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English