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Last Updated: March 21, 2026

Details for New Drug Application (NDA): 208546


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NDA 208546 describes RIVAROXABAN, which is a drug marketed by Alkem Labs Ltd, Lupin Ltd, Aiping Pharm Inc, Alembic, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Biocon Pharma, Breckenridge, Dr Reddys, Invagen Pharms, Macleods Pharms Ltd, MSN, Regcon Holdings, Sciegen Pharms, Sunshine, and Taro, and is included in nineteen NDAs. It is available from seventeen suppliers. Additional details are available on the RIVAROXABAN profile page.

The generic ingredient in RIVAROXABAN is rivaroxaban. There are thirty-five drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
Summary for 208546
Tradename:RIVAROXABAN
Applicant:Msn
Ingredient:rivaroxaban
Patents:0
Pharmacology for NDA: 208546
Mechanism of ActionFactor Xa Inhibitors
Medical Subject Heading (MeSH) Categories for 208546
Factor Xa Inhibitors
Suppliers and Packaging for NDA: 208546
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVAROXABAN rivaroxaban TABLET;ORAL 208546 ANDA Novadoz Pharmaceuticals LLC 72205-416 72205-416-02 10 BLISTER PACK in 1 CARTON (72205-416-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK
RIVAROXABAN rivaroxaban TABLET;ORAL 208546 ANDA Novadoz Pharmaceuticals LLC 72205-416 72205-416-03 30 TABLET, FILM COATED in 1 BOTTLE (72205-416-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Oct 24, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Oct 24, 2025TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength15MG
Approval Date:Oct 24, 2025TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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