Details for New Drug Application (NDA): 208544
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NDA 208544 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 sixteen 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 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. Twenty suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
Summary for 208544
| Tradename: | RIVAROXABAN |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | rivaroxaban |
| Patents: | 0 |
Pharmacology for NDA: 208544
| Mechanism of Action | Factor Xa Inhibitors |
Medical Subject Heading (MeSH) Categories for 208544
Suppliers and Packaging for NDA: 208544
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIVAROXABAN | rivaroxaban | TABLET;ORAL | 208544 | ANDA | Aurobindo Pharma Limited | 59651-849 | 59651-849-18 | 180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18) |
| RIVAROXABAN | rivaroxaban | TABLET;ORAL | 208544 | ANDA | Aurobindo Pharma Limited | 59651-849 | 59651-849-60 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-849-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Apr 10, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 15, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | May 15, 2025 | TE: | AB | RLD: | No | ||||
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