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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 211865


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NDA 211865 describes RANOLAZINE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Allied, Amneal, Ani Pharms, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Praxgen, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Unichem, and Vkt Pharma, and is included in twenty-four NDAs. It is available from twenty-seven suppliers. Additional details are available on the RANOLAZINE profile page.

The generic ingredient in RANOLAZINE is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
Summary for 211865
Tradename:RANOLAZINE
Applicant:Sunshine
Ingredient:ranolazine
Patents:0
Medical Subject Heading (MeSH) Categories for 211865

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Mar 23, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Mar 23, 2020TE:ABRLD:No

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