Home Applications 020592 Application 020592
Type NDA
Sponsor LILLY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZYPREXA OLANZAPINE TABLET;ORAL 2.5MG Yes No 002 ZYPREXA OLANZAPINE TABLET;ORAL 5MG Yes Yes 003 ZYPREXA OLANZAPINE TABLET;ORAL 7.5MG Yes No 004 ZYPREXA OLANZAPINE TABLET;ORAL 10MG Yes No 005 ZYPREXA OLANZAPINE TABLET;ORAL 15MG Yes No 006 ZYPREXA OLANZAPINE TABLET;ORAL 20MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020592-001 ZYPREXA OLANZAPINE 2.5MG TABLET / ORAL AB RLD 1996-09-30 N020592-002 ZYPREXA OLANZAPINE 5MG TABLET / ORAL AB RLD, RS 1996-09-30 N020592-003 ZYPREXA OLANZAPINE 7.5MG TABLET / ORAL AB RLD 1996-09-30 N020592-004 ZYPREXA OLANZAPINE 10MG TABLET / ORAL AB RLD 1996-09-30 N020592-005 ZYPREXA OLANZAPINE 15MG TABLET / ORAL AB RLD 1997-09-09 N020592-006 ZYPREXA OLANZAPINE 20MG TABLET / ORAL AB RLD 1997-09-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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.
Product history page 1 of 7 · 246 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 2026-02-19 14:30 UTC 2026-02 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-005 ZYPREXA 15MG TABLET / ORAL AB RLD 1997-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020592-006 ZYPREXA 20MG TABLET / ORAL AB RLD 1997-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020592-001 ZYPREXA 2.5MG TABLET / ORAL AB RLD 1996-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020592-002 ZYPREXA 5MG TABLET / ORAL AB RLD, RS 1996-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020592-003 ZYPREXA 7.5MG TABLET / ORAL AB RLD 1996-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020592-004 ZYPREXA 10MG TABLET / ORAL AB RLD 1996-09-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
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 Zyprexa OLANZAPINE H2-Pharma LLC b418946a-1ab4-4d89-a012-d94fc361a3c4 2026-02-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020592 application number: NDA020592
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 48 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-4112 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4112 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4112 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4112 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4112 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4112 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4115 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4115 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4115 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4115 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4115 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4115 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4116 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4116 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4116 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4116 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4116 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4116 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4117 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4117 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4117 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4117 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4117 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4117 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4415 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4415 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4415 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4415 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4415 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4415 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4420 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4420 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4420 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4420 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4420 Zyprexa Olanzapine Eli Lilly and Company NDA Current 0002-4420 Zyprexa Olanzapine Eli Lilly and Company NDA Current 21695-140 Zyprexa Olanzapine Rebel Distributors Corp NDA Current 21695-142 Zyprexa Olanzapine Rebel Distributors Corp NDA Current 21695-144 Zyprexa Olanzapine Rebel Distributors Corp NDA Current 49999-606 Zyprexa Olanzapine Lake Erie Medical DBA Quality Care Products LLC NDA Current 52959-579 Zyprexa Olanzapine H.J. Harkins Company, Inc. NDA Current 55289-213 Zyprexa Olanzapine PD-Rx Pharmaceuticals, Inc. NDA Current 68258-7090 Zyprexa Olanzapine Dispensing Solutions, Inc. NDA Current 68258-7091 Zyprexa Olanzapine Dispensing Solutions, Inc. NDA Current 68258-7092 Zyprexa Olanzapine Dispensing Solutions, Inc. NDA Current 68258-7093 Zyprexa Olanzapine Dispensing Solutions, Inc. NDA Current 70518-1465 Zyprexa Olanzapine REMEDYREPACK INC. NDA Current 70518-1465 Zyprexa Olanzapine REMEDYREPACK INC. NDA Current