Home Applications 021520 Application 021520
Type NDA
Sponsor LILLY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 3MG BASE Yes No 002 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 6MG BASE Yes No 003 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 6MG BASE Yes Yes 004 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 25MG BASE;EQ 12MG BASE Yes No 005 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE;ORAL EQ 50MG BASE;EQ 12MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N021520-001 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-04-09 N021520-002 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-12-24 N021520-003 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-12-24 N021520-004 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-12-24 N021520-005 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-12-24
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 4 of 6 · 220 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 2021-03-12 10:30 UTC 2021-03 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 180 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 29 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-3230 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3230 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3230 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3230 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3230 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3230 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3230 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3230 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3231 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3231 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3231 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3231 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3231 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3231 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3231 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3231 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3232 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3233 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3233 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3233 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3233 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3233 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3233 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3234 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3234 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3234 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3234 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3234 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current 0002-3234 Symbyax Olanzapine and Fluoxetine hydrochloride Eli Lilly and Company NDA Current