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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 077135


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NDA 077135 describes VALACYCLOVIR HYDROCHLORIDE, which is a drug marketed by Adaptis, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hetero Labs Ltd V, Hikma, Jubilant Generics, Mylan, Mylan Pharms Inc, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Watson Labs Inc, Yiling, and Zydus Lifesciences, and is included in sixteen NDAs. It is available from forty-one suppliers. Additional details are available on the VALACYCLOVIR HYDROCHLORIDE profile page.

The generic ingredient in VALACYCLOVIR HYDROCHLORIDE is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
Summary for 077135
Tradename:VALACYCLOVIR HYDROCHLORIDE
Applicant:Cipla
Ingredient:valacyclovir hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077135
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 077135
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 077135 ANDA PD-Rx Pharmaceuticals, Inc. 43063-778 43063-778-10 10 TABLET in 1 BOTTLE, PLASTIC (43063-778-10)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 077135 ANDA PD-Rx Pharmaceuticals, Inc. 43063-778 43063-778-14 14 TABLET in 1 BOTTLE, PLASTIC (43063-778-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:May 24, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1GM BASE
Approval Date:May 24, 2010TE:ABRLD:No

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