Details for New Drug Application (NDA): 213114
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NDA 213114 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 nineteen NDAs. It is available from fifteen 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
Summary for 213114
| Tradename: | RIVAROXABAN |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | rivaroxaban |
| Patents: | 0 |
Pharmacology for NDA: 213114
| Mechanism of Action | Factor Xa Inhibitors |
Medical Subject Heading (MeSH) Categories for 213114
Suppliers and Packaging for NDA: 213114
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIVAROXABAN | rivaroxaban | TABLET;ORAL | 213114 | ANDA | Macleods Pharmaceuticals Limited | 33342-488 | 33342-488-09 | 60 TABLET, FILM COATED in 1 BOTTLE (33342-488-09) |
| RIVAROXABAN | rivaroxaban | TABLET;ORAL | 213114 | ANDA | Macleods Pharmaceuticals Limited | 33342-488 | 33342-488-57 | 180 TABLET, FILM COATED in 1 BOTTLE (33342-488-57) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | May 14, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 14, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | May 14, 2025 | TE: | AB | RLD: | No | ||||
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