Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201506
Company: JUBILANT GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription AB No No
VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET;ORAL Prescription AB 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
04/03/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2012 SUPPL-1 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

VALACYCLOVIR HYDROCHLORIDE

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 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 078656 WEST-WARD PHARMS INT
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 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 078656 WEST-WARD PHARMS INT
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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