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Details for New Drug Application (NDA): 203047

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NDA 203047 describes VALACYCLOVIR HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Jubilant Generics, Dr Reddys Labs Ltd, Wockhardt, Mylan Pharms Inc, Cipla Ltd, Hetero Labs Ltd V, Teva Pharms, Roxane, Mylan, Watson Labs Inc, Sandoz, Aurobindo Pharma, and Sun Pharm Inds Ltd, and is included in fourteen NDAs. It is available from forty-four suppliers. Additional details are available on the VALACYCLOVIR HYDROCHLORIDE profile page.

The generic ingredient in VALACYCLOVIR HYDROCHLORIDE is valacyclovir hydrochloride. There are twenty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.

Summary for NDA: 203047

Hetero Labs Ltd V
valacyclovir hydrochloride
Therapeutic Class:Antivirals

Pharmacology for NDA: 203047

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 203047

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
valacyclovir hydrochloride
TABLET;ORAL 203047 ANDA Camber Pharmaceuticals, Inc. 31722-704 31722-704-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-704-01)
valacyclovir hydrochloride
TABLET;ORAL 203047 ANDA Camber Pharmaceuticals, Inc. 31722-704 31722-704-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-704-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Apr 8, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1GM BASE
Approval Date:Apr 8, 2015TE:ABRLD:No

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