Last Updated: September 28, 2026

Details for New Drug Application (NDA): 216933


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NDA 216933 describes TOLVAPTAN, which is a drug marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd V, Lupin, MSN, Ph Health, and Teva Pharms Inc, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the TOLVAPTAN profile page.

The generic ingredient in TOLVAPTAN is tolvaptan. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
Summary for 216933
Tradename:TOLVAPTAN
Applicant:Teva Pharms Inc
Ingredient:tolvaptan
Patents:0
Suppliers and Packaging for NDA: 216933
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLVAPTAN tolvaptan TABLET;ORAL 216933 ANDA Teva Pharmaceuticals, Inc. 0480-3311 0480-3311-66 4 BLISTER PACK in 1 CARTON (0480-3311-66) / 1 KIT in 1 BLISTER PACK (0480-3311-14) * 7 TABLET in 1 BLISTER PACK (0480-3266-11) * 7 TABLET in 1 BLISTER PACK (0480-3265-11)
TOLVAPTAN tolvaptan TABLET;ORAL 216933 ANDA Teva Pharmaceuticals, Inc. 0480-3312 0480-3312-66 4 BLISTER PACK in 1 CARTON (0480-3312-66) / 1 KIT in 1 BLISTER PACK (0480-3312-14) * 7 TABLET in 1 BLISTER PACK (0480-4082-11) * 7 TABLET in 1 BLISTER PACK (0480-3265-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jul 21, 2026TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jul 21, 2026TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength45MG
Approval Date:Jul 21, 2026TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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