Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020550
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALTREX | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | Tablet; Oral | Prescription | None | No | No |
| VALTREX | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/15/1995 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/08/2003 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550slr021ltr.pdf |
| 08/29/2003 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550se1-019ltr.pdf | |
| 12/18/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/2002 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/2002 | SUPPL-16 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20550se1-016ltr.pdf |
| 03/14/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/2001 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2001 | SUPPL-13 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf | |
| 06/25/2001 | SUPPL-12 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-550S012_Valacyclovir%20hydrochloride_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-550S012_Valacyclovir.cfm | |
| 04/20/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/25/2001 | SUPPL-10 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf | |
| 04/20/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/22/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/25/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/2003 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550se1-005ltr.pdf | |
| 04/30/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/26/1997 | SUPPL-3 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020550ap.pdf |
| 10/18/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/29/2003 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s019lbl.pdf | |
| 04/01/2003 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s005lbl.pdf | |
| 06/25/2001 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf | |
| 06/25/2001 | SUPPL-12 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s12lbl.pdf | |
| 06/25/2001 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf |