Orange Book product · Generic (ANDA)
TOLVAPTAN
TOLVAPTAN
At a glance
Nov 10, 2025
Approved
Generic (ANDA)
Application
AB2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 10, 2025
7 mo ago
Today
Pharmaceutical detail
Active ingredient
TOLVAPTAN
Strength
15MG
Dosage form
TABLET
Route
ORAL
TE code
AB2
Application
ANDA 218381
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TOLVAPTAN
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- 2009SAMSCABrand (NDA)
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- 2026TOLVAPTANGeneric (ANDA)
ANDA 220147 · ALKEM LABS LTD
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ANDA 216063 · LUPIN
- 2023TOLVAPTANGeneric (ANDA)
ANDA 216949 · MSN
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ANDA 211891 · ALKEM LABS LTD
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ANDA 207605 · APOTEX
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ANDA 205646 · HETERO LABS LTD V
- 2022TOLVAPTANGeneric (ANDA)
ANDA 206119 · PH HEALTH
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
