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VALACYCLOVIR HYDROCHLORIDE

ANDA

VALACYCLOVIR HYDROCHLORIDE | A203047 | HETERO LABS LTD UNIT V

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VALTREX(TE code: AB)

API Supply Chain19 active DMFs6 inactive

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

SUN PHARMACEUTICAL INDUSTRIES LTDVALACYCLOVIR HYDROCHLORIDE USP (HYDROUS)

DMF 163002002

CIPLA LTDVALACYCLOVIR HYDROCHLORIDE DIHYDRATE USP

DMF 172232003

FLAMMA SPAVALACYCLOVIR HYDROCHLORIDE

DMF 177942004

MATRIX PHARMACORP PRIVATE LTDVALACYCLOVIR HYDROCHLORIDE USP

DMF 179432004

HETERO DRUGS LTDVALACYCLOVIR HYDROCHLORIDE MONOHYDRATE

DMF 206592007

WOCKHARDT LTDVALACYCLOVIR HYDROCHLORIDE

DMF 210102007

APOTEX PHARMACHEM INDIA PVT LTDVALACYCLOVIR HYDROCHLORIDE MONOHYDRATE USP

DMF 214872008

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

DMF 216882008

JUBILANT PHARMOVA LTDVALACYCLOVIR HYDROCHLORIDE

DMF 245772011

PIRAMAL PHARMA LTDVALACYCLOVIR HYDROCHLORIDE

DMF 265462012

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDVALACYCLOVIR HYDROCHLORIDE ANHYDROUS FORM I

DMF 274532013

DIVIS LABORATORIES LTDVALACYCLOVIR HYDROCHLORIDE USP (HYDROUS FORM)

DMF 289362014

SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDVALACYCLOVIR HYDROCHLORIDE

DMF 289692015

HIKAL LTDVALACYCLOVIR HYDROCHLORIDE USP

DMF 304562016

AURORE LIFE SCIENCES PRIVATE LTDVALACYCLOVIR HYDROCHLORIDE USP

DMF 347432020

YICHANG TIANREN PHARMACEUTICAL CO LTDVALACYCLOVIR HYDROCHLORIDE

DMF 353962021

AURORE LIFE SCIENCES PRIVATE LTDVALACYCLOVIR HYDROCHLORIDE USP

DMF 362022021

ZYDUS LIFESCIENCES LTDVALACYCLOVIR HYDROCHLORIDE USP

DMF 378552022

ATUL BIOSCIENCE LTDVALACYCLOVIR HYDROCHLORIDE USP

DMF 415852025

OLON SPAInactiveVALACYCLOVIR HYDROCHLORIDE MONOHYDRATE

DMF 189402005

LUPIN LTDInactiveVALACYCLOVIR HYDROCHLORIDE

DMF 204542007

DR REDDYS LABORATORIES LTDInactiveVALACYCLOVIR HYDROCHLORIDE

DMF 209822007

MYLAN LABORATORIES LTDInactiveVALACYCLOVIR HYDROCHLORIDE USP (VCR)

DMF 228932009

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveVALACYCLOVIR HYDROCHLORIDE

DMF 246942011

HUBEI YITAI PHARMACEUTICAL CO LTDInactiveVALACYCLOVIR HYDROCHLORIDE(NON-STERILE, BULK FORM)

DMF 249202011

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

Products (2)

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#001 — EQ 500MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 8, 2015

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 8, 2015