Details for New Drug Application (NDA): 216949
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NDA 216949 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.
Pharmacology for NDA: 216949
| Mechanism of Action | Vasopressin V2 Receptor Antagonists |
Suppliers and Packaging for NDA: 216949
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLVAPTAN | tolvaptan | TABLET;ORAL | 216949 | ANDA | Novadoz Pharmaceuticals LLC | 72205-130 | 72205-130-11 | 1 BLISTER PACK in 1 CARTON (72205-130-11) / 10 TABLET in 1 BLISTER PACK |
| TOLVAPTAN | tolvaptan | TABLET;ORAL | 216949 | ANDA | Novadoz Pharmaceuticals LLC | 72205-131 | 72205-131-11 | 1 BLISTER PACK in 1 CARTON (72205-131-11) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Jun 21, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Jun 21, 2023 | TE: | AB | RLD: | No | ||||
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