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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201380

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NDA 201380 describes AMLODIPINE BESYLATE, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Apotex, Aurobindo Pharma, China Resources, Cipla Ltd, Dr Reddys Labs Ltd, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Polygen Pharms, Puracap Pharm, Sovereign Pharms, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine Lake, Teva, Torrent Pharms, Unichem Labs Ltd, Upsher-smith Labs, Vintage, Vivimed Global, Watson Labs, West-ward Pharms Int, Wockhardt, Yaopharma Co Ltd, Zydus Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Par Pharm, Teva Pharms, Watson Labs Inc, Alembic Pharms Ltd, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Lupin Ltd, and is included in sixty-six NDAs. It is available from seventy-seven 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 fifty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 201380
Tradename:AMLODIPINE BESYLATE
Applicant:Macleods Pharms Ltd
Ingredient:amlodipine besylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201380
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 201380
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 201380 ANDA Macleods Pharmaceuticals Limited 33342-015 N 33342-015-10
AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 201380 ANDA Macleods Pharmaceuticals Limited 33342-015 N 33342-015-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Apr 13, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Apr 13, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
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Baxter
US Army
Healthtrust
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McKinsey

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