Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022257
Company: HOFFMANN LA ROCHE
Company: HOFFMANN LA ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALCYTE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 08/28/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
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 |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/02/2018 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert |
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-7 | 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 | |
| 07/14/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/2015 | SUPPL-5 | 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-4 | 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-3 | Labeling-Patient Package Insert |
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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/02/2018 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf | |
| 08/02/2018 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf | |
| 06/22/2017 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf | |
| 06/22/2017 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf | |
| 04/23/2015 | SUPPL-5 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf | |
| 03/28/2013 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf | |
| 08/05/2010 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf | |
| 08/28/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf |
VALCYTE
FOR SOLUTION;ORAL; 50MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VALCYTE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | Yes | AB | 022257 | HOFFMANN LA ROCHE |
| VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 205220 | ACTAVIS LABS FL INC |
| VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 212890 | AJANTA PHARMA LTD |
| VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 213306 | GRANULES PHARMS |
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