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Serving 500+ biopharmaceutical companies globally:

Covington
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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090682

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NDA 090682 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, West-ward Pharms Int, Mylan, Watson Labs Inc, Sandoz, Aurobindo Pharma, and Sun Pharm Inds Ltd, and is included in fourteen NDAs. It is available from forty-six 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-eight suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.

Summary for NDA: 090682

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 090682

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 090682

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride
TABLET;ORAL 090682 ANDA Major Pharmaceuticals 0904-6565 0904-6565-07 30 BLISTER PACK in 1 CARTON (0904-6565-07) > 1 TABLET, FILM COATED in 1 BLISTER PACK
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride
TABLET;ORAL 090682 ANDA Major Pharmaceuticals 0904-6565 0904-6565-61 100 BLISTER PACK in 1 CARTON (0904-6565-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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


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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
McKesson
Novartis
McKinsey
Healthtrust
Farmers Insurance
Cerilliant
Teva
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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