Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020550
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

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