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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021304
Company: CHEPLAPHARM

Summary Review

Products on NDA 021304

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALCYTE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2001	ORIG-1	Approval	Type 2 - New Active Ingredient	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21304lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21304ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21304_Valcyte.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021304.s17_22257s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022257Orig1s012, 021304Orig1s017ltr.pdf
11/24/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021304s016,022257s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022257Orig1s011;021304Orig1s016ltr.pdf
10/21/2020	SUPPL-15	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022257Orig1s010,021304Orig1s015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022257Orig1s010, 021304Orig1s015ltr.pdf
08/02/2018	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021304Orig1s014,022257Orig1s009ltr.pdf
06/22/2017	SUPPL-12	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021304Orig1s012,022257Orig1s007ltr.pdf
04/23/2015	SUPPL-11	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021304Orig1s011,022257Orig1s005ltr.pdf
03/28/2013	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021304Orig1s010,022257Orig1s004ltr.pdf
08/05/2010	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021304s008,022257s003ltr.pdf
08/28/2009	SUPPL-7	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022257s000_021304s07ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257_021304s007_valcyte_valganciclovir hydrochloride_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022257Original-1_021304s007sumr.pdf
01/31/2006	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021304s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021304s004ltr.pdf
09/12/2003	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21304se1-001_valcyte_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21304se1-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021304_S001_VALCYTE.pdf

Labels for NDA 021304

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021304.s17_22257s12lbl.pdf
11/24/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021304s016,022257s011lbl.pdf
10/21/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022257Orig1s010,021304Orig1s015Lbl.pdf
10/21/2020	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022257Orig1s010,021304Orig1s015Lbl.pdf
10/21/2020	SUPPL-15	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022257Orig1s010,021304Orig1s015Lbl.pdf
08/02/2018	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022257s009,021304s014lbl.pdf
06/22/2017	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf
06/22/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021304s012,022257s007lbl.pdf
04/23/2015	SUPPL-11	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022257s005,021304s011lbl.pdf
03/28/2013	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021304s010,022257s004lbl.pdf
08/05/2010	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf
08/28/2009	SUPPL-7	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf
01/31/2006	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021304s004lbl.pdf
09/12/2003	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21304se1-001_valcyte_lbl.pdf
03/29/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21304lbl.pdf

Therapeutic Equivalents for NDA 021304

VALCYTE

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	CHEPLAPHARM
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	212234	AJANTA PHARMA LTD
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	203511	DR REDDYS
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	205166	HETERO LABS LTD V
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	212876	SOMERSET THERAPS LLC
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	218027	SPH ZHONGXI PHARM
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET;ORAL	Prescription	No	AB	200790	STRIDES PHARMA INTL

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