Details for New Drug Application (NDA): 216063
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NDA 216063 describes TOLVAPTAN, which is a drug marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd V, Lupin Ltd, MSN, and Ph Health, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the TOLVAPTAN profile page.
The generic ingredient in TOLVAPTAN is tolvaptan. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
The generic ingredient in TOLVAPTAN is tolvaptan. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
Pharmacology for NDA: 216063
| Mechanism of Action | Vasopressin V2 Receptor Antagonists |
Suppliers and Packaging for NDA: 216063
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLVAPTAN | tolvaptan | TABLET;ORAL | 216063 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-238 | 70748-238-06 | 30 TABLET in 1 BOTTLE (70748-238-06) |
| TOLVAPTAN | tolvaptan | TABLET;ORAL | 216063 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-239 | 70748-239-06 | 30 TABLET in 1 BOTTLE (70748-239-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Apr 23, 2025 | TE: | AB2 | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 8, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Apr 23, 2025 | TE: | AB2 | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 8, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 45MG | ||||
| Approval Date: | Apr 23, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 8, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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