Home Applications 021253 Application 021253
Type NDA
Sponsor LILLY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZYPREXA OLANZAPINE INJECTABLE;INTRAMUSCULAR 10MG/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021253-001 ZYPREXA OLANZAPINE 10MG/VIAL POWDER / INTRAMUSCULAR AP RLD, RS 2004-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021253-001 AP
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 · 43 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 N021253-001 ZYPREXA 10MG/VIAL POWDER / INTRAMUSCULAR AP RLD, RS 2004-03-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021253-001 ZYPREXA 10MG/VIAL POWDER / INTRAMUSCULAR AP RLD, RS 2004-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021253-001 ZYPREXA 10MG/VIAL POWDER / INTRAMUSCULAR AP RLD, RS 2004-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021253-001 ZYPREXA 10MG/VIAL INJECTABLE / INTRAMUSCULAR AP RLD, RS 2004-03-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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): 021253 application number: NDA021253
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-7597 ZYPREXA Olanzapine Eli Lilly and Company NDA Current 0002-7597 ZYPREXA Olanzapine Eli Lilly and Company NDA Current 0002-7597 ZYPREXA Olanzapine Eli Lilly and Company NDA Current 0002-7597 ZYPREXA Olanzapine Eli Lilly and Company NDA Current 0002-7597 ZYPREXA Olanzapine Eli Lilly and Company NDA Current 0002-7597 ZYPREXA Olanzapine Eli Lilly and Company NDA Current 64725-7597 ZYPREXA Olanzapine TYA Pharmaceuticals NDA Current