Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021304
Company: CHEPLAPHARM
Company: CHEPLAPHARM
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 |
---|---|---|---|---|---|
12/23/2021 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021304.s17_22257s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022257Orig1s012, 021304Orig1s017ltr.pdf | |
11/24/2020 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021304s016,022257s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022257Orig1s011;021304Orig1s016ltr.pdf | |
10/21/2020 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022257Orig1s010,021304Orig1s015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022257Orig1s010, 021304Orig1s015ltr.pdf | |
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 |
---|---|---|---|---|---|
12/23/2021 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021304.s17_22257s12lbl.pdf | |
11/24/2020 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021304s016,022257s011lbl.pdf | |
10/21/2020 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022257Orig1s010,021304Orig1s015Lbl.pdf | |
10/21/2020 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022257Orig1s010,021304Orig1s015Lbl.pdf | |
10/21/2020 | SUPPL-15 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022257Orig1s010,021304Orig1s015Lbl.pdf | |
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 | CHEPLAPHARM |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 212234 | AJANTA PHARMA LTD |
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 | 203511 | DR REDDYS |
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 | 205166 | HETERO LABS LTD V |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 200790 | STRIDES PHARMA |