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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 211707


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NDA 211707 describes RANOLAZINE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Ani Pharms, Aurobindo Pharma, Cadila, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, I3 Pharms, Lupin Ltd, Mankind Pharma, Micro Labs, Novast Labs, Piramal Hlthcare Uk, Praxgen, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Unichem, and Vkt Pharma, and is included in twenty-four NDAs. It is available from twenty-six 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-six suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
Summary for 211707
Tradename:RANOLAZINE
Applicant:Sun Pharm
Ingredient:ranolazine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 211707
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211707 ANDA Sun Pharmaceutical Industries, Inc. 63304-017 63304-017-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-017-05)
RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 211707 ANDA Sun Pharmaceutical Industries, Inc. 63304-017 63304-017-28 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-017-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:May 28, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:May 28, 2019TE:ABRLD:No

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