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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 216995


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NDA 216995 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 216995
Tradename:RIVAROXABAN
Applicant:Aiping Pharm Inc
Ingredient:rivaroxaban
Patents:0
Pharmacology for NDA: 216995
Mechanism of ActionFactor Xa Inhibitors
Medical Subject Heading (MeSH) Categories for 216995
Factor Xa Inhibitors
Suppliers and Packaging for NDA: 216995
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVAROXABAN rivaroxaban TABLET;ORAL 216995 ANDA Changzhou Pharmaceutical Factory 55488-0540 55488-0540-1 30 TABLET, FILM COATED in 1 BOTTLE (55488-0540-1)
RIVAROXABAN rivaroxaban TABLET;ORAL 216995 ANDA Changzhou Pharmaceutical Factory 55488-0541 55488-0541-1 30 TABLET, FILM COATED in 1 BOTTLE (55488-0541-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 14, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:May 14, 2025TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 14, 2025TE:ABRLD:No

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Preferred Citation:

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