FDA.reportPublic FDA data

Application 219048

Type
ANDA
Sponsor
OMNIVIUM PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINEPOWDER;INTRAMUSCULAR10MG/VIALNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219048-001OLANZAPINEOLANZAPINE10MG/VIALPOWDER / INTRAMUSCULARAP2026-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219048-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219048-001OLANZAPINE10MG/VIALPOWDER / INTRAMUSCULARAP2026-01-2384e616aacf4f…
2026-08-18 06:07:402026-07A219048-001OLANZAPINE10MG/VIALPOWDER / INTRAMUSCULARAP2026-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219048-001OLANZAPINE10MG/VIALPOWDER / INTRAMUSCULARAP2026-01-23011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219048-001OLANZAPINE10MG/VIALPOWDER / INTRAMUSCULARAP2026-01-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219048-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A219048-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219048-001AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219048-001AP1a50c72e98297…

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 4 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEQilu Pharmaceutical Co., Ltd.12ce860a-6f22-4db6-8acf-786b40f5a5a52025-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEAmerican Health Packaging75616c31-8fed-4014-a9f2-4a028eccd5862025-10-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC40187874-447a-de20-e063-6394a90aafe72025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC3ed78a7d-4014-d280-e063-6294a90a8ee92025-09-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee2025-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
Olanzapine IntramuscularOLANZAPINEPAI Holdings, LLC dba PAI Pharma9d9f25d5-4513-434a-a37a-392a0c978f2e2025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC37c88965-c51d-946d-e063-6394a90a012c2025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepack1866a03c-eac9-44a1-8f33-7dc6e8a8c06a2025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepack3c9963b1-c498-48a0-a3a1-1eaa6a1028fc2025-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepackf6fd7ceb-1457-4c3e-9d30-4f658f39d37d2025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepackc47f90fc-49fe-4f60-9da8-1365a1650dd92025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepackdcf8fcbf-636c-41ad-8084-c65ac2f117cc2025-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepack8586e828-34e7-4eb4-a933-6c688927478f2025-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepackd5a9f78e-56f4-4249-800c-5f52a99fa84b2025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepackd3857220-d9ff-4820-bf53-f2384b59a1a62025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepacked93d6b9-912a-444a-a695-439d0bfb877a2025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.9847a0e4-24fc-f4e8-e053-2995a90a961e2025-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC325d5d69-5133-79ea-e063-6294a90afdd02025-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEJubilant Cadista Pharmacuticals Inc.028aa88e-fa50-7aa8-cc0b-97c0c9a0357c2025-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECadila Pharmaceuticals Limited2ae07ad4-4e58-4740-9f02-035ec061fefc2025-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.