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Last Updated: November 13, 2024

Details for New Drug Application (NDA): 207605


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NDA 207605 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 207605
Tradename:TOLVAPTAN
Applicant:Apotex
Ingredient:tolvaptan
Patents:0
Pharmacology for NDA: 207605
Suppliers and Packaging for NDA: 207605
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLVAPTAN tolvaptan TABLET;ORAL 207605 ANDA Apotex Corp. 60505-4317 60505-4317-0 1 BLISTER PACK in 1 CARTON (60505-4317-0) / 10 TABLET in 1 BLISTER PACK
TOLVAPTAN tolvaptan TABLET;ORAL 207605 ANDA Apotex Corp. 60505-4317 60505-4317-3 30 TABLET in 1 BOTTLE (60505-4317-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:May 19, 2020TE: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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