Home Applications 216137 Application 216137
Type ANDA
Sponsor ZYDUS WORLDWIDE DMCC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE CAPSULE;ORAL 40MG No No 002 VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE CAPSULE;ORAL 60MG No No 003 VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE CAPSULE;ORAL 80MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216137-001 VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL 2024-08-07 A216137-002 VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL 2024-08-07 A216137-003 VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL 2024-08-07
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 2 · 42 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 2026-09-14 22:38:34 2026-08 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL 2024-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL 2024-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL 2024-08-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL 2024-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL 2024-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL 2024-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL 2024-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL 2024-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL 2024-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL 2024-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL 2024-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL 2024-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL 2024-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL 2024-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL 2024-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL 2024-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL 2024-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL 2024-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL AB 2024-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL AB 2024-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL AB 2024-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL AB 2024-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL AB 2024-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL AB 2024-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL AB 2024-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL AB 2024-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL AB 2024-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL AB 2024-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL AB 2024-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL AB 2024-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL AB 2024-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL AB 2024-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL AB 2024-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL AB 2024-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL AB 2024-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL AB 2024-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL AB 2024-08-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216137-002 VALBENAZINE TOSYLATE EQ 60MG BASE CAPSULE / ORAL AB 2024-08-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216137-003 VALBENAZINE TOSYLATE EQ 80MG BASE CAPSULE / ORAL AB 2024-08-07 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216137-001 VALBENAZINE TOSYLATE EQ 40MG BASE CAPSULE / ORAL 2024-08-07 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 72935 ORIG 2022-12-20