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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 205646


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NDA 205646 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.
Summary for 205646
Tradename:TOLVAPTAN
Applicant:Hetero Labs Ltd V
Ingredient:tolvaptan
Patents:0
Pharmacology for NDA: 205646
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:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jul 16, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Sep 6, 2022TE:ABRLD:No

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