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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090011


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NDA 090011 describes AMLODIPINE BESYLATE AND VALSARTAN, which is a drug marketed by Alembic, Aurobindo Pharma, Hetero Labs, Lupin, Mylan, Novel Labs Inc, Strides Pharma, Teva Pharms Usa, and Torrent, and is included in nine NDAs. It is available from eight 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. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.
Summary for 090011
Suppliers and Packaging for NDA: 090011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090011 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-844 23155-844-03 30 TABLET in 1 BOTTLE, PLASTIC (23155-844-03)
AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090011 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-844 23155-844-09 90 TABLET in 1 BOTTLE, PLASTIC (23155-844-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;160MG
Approval Date:Mar 28, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;160MG
Approval Date:Mar 28, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;320MG
Approval Date:Mar 28, 2013TE:ABRLD:No

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