Details for New Drug Application (NDA): 205646
✉ Email this page to a colleague
NDA 205646 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.
Summary for 205646
| Tradename: | TOLVAPTAN |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | tolvaptan |
| Patents: | 0 |
Pharmacology for NDA: 205646
| Mechanism of Action | Vasopressin V2 Receptor Antagonists |
Suppliers and Packaging for NDA: 205646
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLVAPTAN | tolvaptan | TABLET;ORAL | 205646 | ANDA | Camber Pharmaceuticals, Inc. | 31722-868 | 31722-868-01 | 10 BLISTER PACK in 1 CARTON (31722-868-01) / 10 TABLET in 1 BLISTER PACK |
| TOLVAPTAN | tolvaptan | TABLET;ORAL | 205646 | ANDA | Camber Pharmaceuticals, Inc. | 31722-868 | 31722-868-02 | 10 BLISTER PACK in 1 CARTON (31722-868-02) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Jul 16, 2021 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Sep 6, 2022 | TE: | AB1 | RLD: | No | ||||
Complete Access Available with Subscription
