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Details for New Drug Application (NDA): 076859

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NDA 076859 describes AMLODIPINE BESYLATE, which is a drug marketed by Sovereign Pharms, Wockhardt, Vintage, Vivimed Labs, Mylan, Apotex, Aurobindo Pharma, Polygen Pharms, Mylan Pharms Inc, 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, Roxane, 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, 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-five NDAs. It is available from sixty-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 forty-eight 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 NDA: 076859

amlodipine besylate

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Sep 10, 2007TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 10, 2007TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 10, 2007TE:RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.