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Last Updated: September 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208862

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NDA 208862 describes RANOLAZINE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Ani Pharms Inc, Cadila, Cipla, Glenmark Pharms Ltd, Lupin Ltd, Mankind Pharma, Micro Labs, Sciegen Pharms Inc, Sun Pharm, Sungen Pharma, and Sunshine Lake, and is included in thirteen NDAs. It is available from fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
Summary for 208862
Tradename:RANOLAZINE
Applicant:Actavis Elizabeth
Ingredient:ranolazine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 208862 ANDA Actavis Pharma, Inc. 45963-418 45963-418-06 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-06)
RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 208862 ANDA Actavis Pharma, Inc. 45963-418 45963-418-50 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-50)

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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