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Serving 500+ biopharmaceutical companies globally:

Argus Health
Novartis
Moodys
Express Scripts
McKesson
Baxter
Julphar
UBS
Accenture
Teva

Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077530

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NDA 077530 describes VALSARTAN, which is a drug marketed by Amneal Pharms, Hetero Labs Ltd V, Prinston Inc, Aurobindo Pharma Ltd, Torrent Pharms Ltd, Ivax Pharms, Jubilant Generics, Watson Labs Inc, Mylan Pharms Inc, Alembic Pharms Ltd, Lupin Ltd, Ohm Labs Inc, Macleods Pharms Ltd, Watson Labs Teva, and Apotex Inc, and is included in twenty-one NDAs. It is available from thirty-two suppliers. Additional details are available on the VALSARTAN profile page.

The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Summary for NDA: 077530

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077530

Suppliers and Packaging for NDA: 077530

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN
valsartan
TABLET;ORAL 077530 ANDA Teva Pharmaceuticals USA Inc 0093-7433 0093-7433-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-7433-98)
VALSARTAN
valsartan
TABLET;ORAL 077530 ANDA AvKARE, Inc. 42291-880 42291-880-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-880-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jan 4, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jan 4, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jan 4, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Fuji
Boehringer Ingelheim
Chubb
Deloitte
Moodys
US Army
Queensland Health
Farmers Insurance
Dow

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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