Details for New Drug Application (NDA): 218445
✉ Email this page to a colleague
NDA 218445 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 Inc, Sunshine, and Taro, and is included in eighteen NDAs. It is available from fourteen 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. Eighteen suppliers are listed for this compound. 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. Eighteen suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
Summary for 218445
| Tradename: | RIVAROXABAN |
| Applicant: | Regcon Holdings |
| Ingredient: | rivaroxaban |
| Patents: | 0 |
Pharmacology for NDA: 218445
| Mechanism of Action | Factor Xa Inhibitors |
Medical Subject Heading (MeSH) Categories for 218445
Suppliers and Packaging for NDA: 218445
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIVAROXABAN | rivaroxaban | TABLET;ORAL | 218445 | ANDA | Indoco Remedies Limited | 14445-147 | 14445-147-10 | 10 BLISTER PACK in 1 CARTON (14445-147-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-147-02) |
| RIVAROXABAN | rivaroxaban | TABLET;ORAL | 218445 | ANDA | Indoco Remedies Limited | 14445-147 | 14445-147-18 | 180 TABLET, FILM COATED in 1 BOTTLE (14445-147-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Aug 11, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 11, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Aug 11, 2025 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
