Home Applications 216063 Application 216063
Type ANDA
Sponsor LUPIN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOLVAPTAN TOLVAPTAN TABLET;ORAL 15MG No No 002 TOLVAPTAN TOLVAPTAN TABLET;ORAL 30MG No No 003 TOLVAPTAN TOLVAPTAN TABLET;ORAL 45MG No No 004 TOLVAPTAN TOLVAPTAN TABLET;ORAL 60MG No No 005 TOLVAPTAN TOLVAPTAN TABLET;ORAL 90MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216063-001 TOLVAPTAN TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 A216063-002 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 A216063-003 TOLVAPTAN TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 A216063-004 TOLVAPTAN TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 A216063-005 TOLVAPTAN TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
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 2026-02-19 14:30 UTC 2026-02 A216063-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216063-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216063-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216063-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216063-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216063-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216063-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216063-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216063-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216063-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TOLVAPTAN TOLVAPTAN Lupin Pharmaceuticals, Inc. 9ba38e23-ca66-4406-92af-bbb8fad00e16 2025-05-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216063 application number: ANDA216063
Documents# Document, Submission type, Date table Document Submission type Date 76689 ORIG 2023-11-29