Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200790
Company: ENDO PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG 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
11/04/2014 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200790Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

VALGANCICLOVIR HYDROCHLORIDE

TABLET;ORAL; EQ 450MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VALCYTE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription Yes AB 021304 HOFFMANN LA ROCHE
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 204750 AUROBINDO PHARMA LTD
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 209672 CIPLA
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 206876 DR REDDYS
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 203511 DR REDDYS LABS LTD
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 200790 ENDO PHARMS INC
VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET;ORAL Prescription No AB 205166 HETERO LABS LTD V

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