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OLANZAPINE EQ 25MG BASE;EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2007-04-09 N021520-002 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-12-24 N021520-003 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-12-24 N021520-004 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 25MG BASE;EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-12-24 N021520-005 SYMBYAX FLUOXETINE HYDROCHLORIDE; OLANZAPINE EQ 50MG BASE;EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-12-24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 2 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 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021520-001 SYMBYAX EQ 25MG BASE;EQ 3MG BASE CAPSULE / ORAL AB RLD 2007-04-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021520-002 SYMBYAX EQ 25MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD 2003-12-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021520-003 SYMBYAX EQ 50MG BASE;EQ 6MG BASE CAPSULE / ORAL AB RLD, RS 2003-12-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021520-004 SYMBYAX EQ 25MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021520-005 SYMBYAX EQ 50MG BASE;EQ 12MG BASE CAPSULE / ORAL AB RLD 2003-12-24 1e350fbaab3a…
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