Home Applications 211891 Application 211891
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOLVAPTAN TOLVAPTAN TABLET;ORAL 30MG No No 002 TOLVAPTAN TOLVAPTAN TABLET;ORAL 60MG No No 003 TOLVAPTAN TOLVAPTAN TABLET;ORAL 15MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211891-001 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 A211891-002 TOLVAPTAN TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 A211891-003 TOLVAPTAN TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 104 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67877-635 Tolvaptan Tolvaptan Ascend Laboratories, LLC ANDA Current 67877-636 Tolvaptan Tolvaptan Ascend Laboratories, LLC ANDA Current 67877-636 Tolvaptan Tolvaptan Ascend Laboratories, LLC ANDA Current 67877-636 Tolvaptan Tolvaptan Ascend Laboratories, LLC ANDA Current 67877-636 Tolvaptan Tolvaptan Ascend Laboratories, LLC ANDA Current 67877-637 Tolvaptan Tolvaptan Ascend Laboratories, LLC ANDA Current 67877-637 Tolvaptan Tolvaptan Ascend Laboratories, LLC ANDA Current 67877-637 Tolvaptan Tolvaptan Ascend Laboratories, LLC ANDA Current 67877-637 Tolvaptan Tolvaptan Ascend Laboratories, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 62171 ORIG 2020-03-17