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Generated: April 29, 2017

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Details for New Drug Application (NDA): 078226

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NDA 078226 describes AMLODIPINE BESYLATE, which is a drug marketed by Sovereign Pharms, Wockhardt, Vintage, Vivimed Labs, Mylan Pharms Inc, Apotex, Aurobindo Pharma, Polygen Pharms, Alkem, Synthon Pharms, Zydus Pharms Usa, Puracap Pharm, Sun Pharm Inds Inc, Gedeon Richter Usa, Lupin, Unichem Labs Ltd, Teva, China Resources, Epic Pharma Llc, Accord Hlthcare, Orchid Hlthcare, Invagen Pharms, Sandoz, Upsher Smith, Genpharm, West-ward Pharms Int, Hikma Pharms, Watson Labs, Cipla Ltd, Torrent Pharms, Sun Pharm Inds Ltd, Amneal Pharms Ny, Macleods Pharms Ltd, Sun Pharm Inds, Dr Reddys Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Mylan, Dr Reddys Labs Inc, Watson Labs Inc, Lupin Pharms, Teva Pharms, Par Pharm, Par Pharm Inc, Alembic Pharms Ltd, Novel Labs Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Lupin Ltd, and is included in sixty-four NDAs. It is available from seventy-one suppliers. There is one patent protecting this drug. Additional details are available on the AMLODIPINE BESYLATE profile page.

The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are forty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for NDA: 078226

Formulation / Manufacturing:see details

Pharmacology for NDA: 078226

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 078226

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amlodipine besylate
TABLET;ORAL 078226 ANDA Major Pharmaceuticals 0904-6369 0904-6369-61 100 TABLET in 1 BOX, UNIT-DOSE (0904-6369-61)
amlodipine besylate
TABLET;ORAL 078226 ANDA Major Pharmaceuticals 0904-6370 0904-6370-61 100 TABLET in 1 BOX, UNIT-DOSE (0904-6370-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 9, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 9, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 9, 2007TE:ABRLD:No

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