Details for New Drug Application (NDA): 206119
✉ Email this page to a colleague
NDA 206119 describes TOLVAPTAN, which is a drug marketed by Alkem Labs Ltd, Apotex, Endo Operations, Hetero Labs Ltd V, and MSN, and is included in five NDAs. It is available from five 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
Summary for 206119
| Tradename: | TOLVAPTAN |
| Applicant: | Endo Operations |
| Ingredient: | tolvaptan |
| Patents: | 0 |
Pharmacology for NDA: 206119
| Mechanism of Action | Vasopressin V2 Receptor Antagonists |
Suppliers and Packaging for NDA: 206119
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLVAPTAN | tolvaptan | TABLET;ORAL | 206119 | ANDA | Endo USA, Inc. | 49884-768 | 49884-768-54 | 1 BLISTER PACK in 1 CARTON (49884-768-54) / 10 TABLET in 1 BLISTER PACK (49884-768-52) |
| TOLVAPTAN | tolvaptan | TABLET;ORAL | 206119 | ANDA | Endo USA, Inc. | 49884-770 | 49884-770-54 | 1 BLISTER PACK in 1 CARTON (49884-770-54) / 10 TABLET in 1 BLISTER PACK (49884-770-52) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Feb 15, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Feb 15, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
