Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020487
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 AB Yes No
VALTREX VALACYCLOVIR HYDROCHLORIDE EQ 1GM 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
06/23/1995 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/19/2010 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020487s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020487s016ltr.pdf
09/02/2008 SUPPL-14 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020487s014ltr.pdf
12/11/2007 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020487s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020487s013ltr.pdf
11/23/2005 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020487s007rel2_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020487s007rel2_ltr.pdf
12/03/2004 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20487s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20487s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-487s005_ValtrexTOC.cfm
01/13/1997 SUPPL-4 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-487s004_ValtrexTOC.cfm
08/09/1996 SUPPL-3 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20-487s003_ValtrexTOC.cfm
09/08/1995 SUPPL-2 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-487s002_ValtrexTOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/19/2010 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020487s016lbl.pdf
09/02/2008 SUPPL-14 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf
12/11/2007 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020487s013lbl.pdf
11/23/2005 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020487s007rel2_lbl.pdf
12/03/2004 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20487s005lbl.pdf

VALTREX

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 090500 APOTEX
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 090682 AUROBINDO PHARMA
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 077135 CIPLA
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 203047 HETERO LABS LTD V
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 078656 HIKMA
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 201506 JUBILANT GENERICS
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 078518 MYLAN PHARMS INC
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 077478 SANDOZ
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076588 SUN PHARM INDS LTD
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 077655 TEVA PHARMS
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 079012 TIME-CAP LABS INC
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 090216 WOCKHARDT
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 079137 ZYDUS PHARMS
VALTREX VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription Yes AB 020487 GLAXOSMITHKLINE

TABLET;ORAL; EQ 1GM BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 090500 APOTEX
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 090682 AUROBINDO PHARMA
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 077135 CIPLA
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 203047 HETERO LABS LTD V
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 078656 HIKMA
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 201506 JUBILANT GENERICS
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 078518 MYLAN PHARMS INC
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 077478 SANDOZ
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 076588 SUN PHARM INDS LTD
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 077655 TEVA PHARMS
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 079012 TIME-CAP LABS INC
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 090216 WOCKHARDT
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription No AB 079137 ZYDUS PHARMS
VALTREX VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription Yes AB 020487 GLAXOSMITHKLINE

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