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VALGANCICLOVIR HYDROCHLORIDE

ANDA

VALGANCICLOVIR HYDROCHLORIDE | A200790 | STRIDES PHARMA INTERNATIONAL AG

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: VALCYTE(TE code: AB)

API Supply Chain17 active DMFs2 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

OLON SPAVALGANCICLOVIR HYDROCHLORIDE AMORPHOUS

DMF 230442009

MATRIX PHARMACORP PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE)

DMF 233222009

MATRIX PHARMACORP PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE) FORM A

DMF 238592010

DR REDDYS LABORATORIES LTDVALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE)

DMF 248182011

DR REDDYS LABORATORIES LTDVALGANCICLOVIR HYDROCHLORIDE USP (AMORPHOUS)

DMF 248312011

APITORIA PHARMA PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 263142012

CALYX CHEMICALS AND PHARMACEUTICALS LTDVALGANCICLOVIR HYDROCHLORIDE

DMF 268892012

CIPLA LTDVALGANCICLOVIR HYDROCHLORIDE USP

DMF 283602014

CORDEN PHARMA COLORADO INCVALGANCICLOVIR HYDROCHLORIDE

DMF 300232015

PHARMATHEN SAVALGANCICLOVIR HYDROCHLORIDE

DMF 315462017

OLON SPAVALGANCICLOVIR HYDROCHLORIDE CRYSTALLINE

DMF 324882018

AURORE LIFE SCIENCES PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP

DMF 346002020

MAITHRI LABORATORIES PRIVATE LTDVALGANCICLOVIR HYDROCHLORIDE USP

DMF 346172020

SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDVALGANCICLOVIR HYDROCHLORIDE

DMF 351072021

AJANTA PHARMA LTDVALGANCICLOVIR HYDROCHLORIDE USP (Crystalline)

DMF 361942021

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDVALGANCICLOVIR HYDROCHLORIDE

DMF 388912023

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDVALGANCICLOVIR HYDROCHLORIDE

DMF 420832025

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveVALGANCICLOVIR HYDROCHLORIDE (NON-STERILE BULK)

DMF 190602005

APOTEX PHARMACHEM INDIA PVT LTDInactiveVALGANCICLOVIR HYDROCHLORIDE USP

DMF 244342010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 10, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 450MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 4, 2014

No patent or exclusivity listings for this strength.