Home Applications 211146 Application 211146
Type ANDA
Sponsor ZYDUS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VORTIOXETINE HYDROBROMIDE VORTIOXETINE HYDROBROMIDE TABLET;ORAL EQ 5MG BASE No No 002 VORTIOXETINE HYDROBROMIDE VORTIOXETINE HYDROBROMIDE TABLET;ORAL EQ 10MG BASE No No 003 VORTIOXETINE HYDROBROMIDE VORTIOXETINE HYDROBROMIDE TABLET;ORAL EQ 20MG BASE No No
Source provenance: Browse the complete Orange Book source catalog .
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 2 of 2 · 72 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 2023-12-20 04:57 UTC 2023-12 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211146-001 VORTIOXETINE HYDROBROMIDE EQ 5MG BASE TABLET / ORAL 2021-09-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211146-002 VORTIOXETINE HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2021-09-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211146-003 VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2021-09-17 cb3db0bc1861…
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 68918 ORIG 2021-10-08