Details for New Drug Application (NDA): 207605
✉ Email this page to a colleague
The generic ingredient in TOLVAPTAN is tolvaptan. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
Pharmacology for NDA: 207605
Mechanism of Action | Vasopressin V2 Receptor Antagonists |
Suppliers and Packaging for NDA: 207605
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOLVAPTAN | tolvaptan | TABLET;ORAL | 207605 | ANDA | Apotex Corp. | 60505-4317 | 60505-4317-0 | 1 BLISTER PACK in 1 CARTON (60505-4317-0) / 10 TABLET in 1 BLISTER PACK |
TOLVAPTAN | tolvaptan | TABLET;ORAL | 207605 | ANDA | Apotex Corp. | 60505-4317 | 60505-4317-3 | 30 TABLET in 1 BOTTLE (60505-4317-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | May 19, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Sep 6, 2022 | TE: | AB | RLD: | No |
Complete Access Available with Subscription