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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 207435


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NDA 207435 describes AMLODIPINE AND OLMESARTAN MEDOXOMIL, which is a drug marketed by Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Micro Labs, Sciegen Pharms Inc, Teva Pharms Usa, Torrent, and Zydus Pharms, and is included in thirteen NDAs. It is available from fifteen suppliers. Additional details are available on the AMLODIPINE AND OLMESARTAN MEDOXOMIL profile page.

The generic ingredient in AMLODIPINE AND OLMESARTAN MEDOXOMIL is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.
Summary for 207435
Suppliers and Packaging for NDA: 207435
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 207435 ANDA Micro Labs Limited 42571-235 42571-235-05 500 TABLET in 1 BOTTLE (42571-235-05)
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 207435 ANDA Micro Labs Limited 42571-235 42571-235-10 1000 TABLET in 1 BOTTLE (42571-235-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;20MG
Approval Date:Nov 2, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;40MG
Approval Date:Nov 2, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;20MG
Approval Date:Nov 2, 2017TE:ABRLD:No

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