Details for New Drug Application (NDA): 205646
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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 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: | 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 |
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