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Serving leading biopharmaceutical companies globally:

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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202713

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NDA 202713 describes AMLODIPINE BESYLATE AND VALSARTAN, which is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Invagen Pharms, Lupin, Mylan Pharms Inc, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the AMLODIPINE BESYLATE AND VALSARTAN profile page.

The generic ingredient in AMLODIPINE BESYLATE AND VALSARTAN is amlodipine besylate; valsartan. There are fifty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.

Summary for 202713

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

Pharmacology for NDA: 202713

Suppliers and Packaging for NDA: 202713

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202713 ANDA Alembic Pharmaceuticals Inc. 62332-205 62332-205-90 90 TABLET, FILM COATED in 1 BOTTLE (62332-205-90)
AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202713 ANDA Alembic Pharmaceuticals Inc. 62332-205 62332-205-71 500 TABLET, FILM COATED in 1 BOTTLE (62332-205-71)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;160MG
Approval Date:Apr 3, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;160MG
Approval Date:Apr 3, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;320MG
Approval Date:Apr 3, 2015TE:ABRLD:No


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