Orange Book product · Generic (ANDA)
TOLVAPTAN
TOLVAPTAN
At a glance
Sep 06, 2022
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 06, 2022
3 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
TOLVAPTAN
Strength
15MG
Dosage form
TABLET
Route
ORAL
TE code
AB1
Application
ANDA 205646
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TOLVAPTAN
- 2018JYNARQUEBrand (NDA)
NDA 204441 · OTSUKA
- 2009SAMSCABrand (NDA)
NDA 022275 · OTSUKA
- 2026TOLVAPTANGeneric (ANDA)
ANDA 220147 · ALKEM LABS LTD
- 2025TOLVAPTANGeneric (ANDA)
ANDA 218381 · APOTEX
- 2025TOLVAPTANGeneric (ANDA)
ANDA 216063 · LUPIN
- 2023TOLVAPTANGeneric (ANDA)
ANDA 216949 · MSN
- 2022TOLVAPTANGeneric (ANDA)
ANDA 211891 · ALKEM LABS LTD
- 2022TOLVAPTANGeneric (ANDA)
ANDA 207605 · APOTEX
- 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.
