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 42.

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
2026-08-18 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
2026-08-18 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 1 of 6 · 103 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEHikma Pharmaceuticals USA Inc.63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d12026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.c47ee16f-5a86-49f2-8d85-5f49a6c8d91e2026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECardinal Health 107, LLC38a89689-efc2-4931-8f65-868dc0248d6a2026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.d349d5b7-5658-46d6-9bba-e6f6361cebb92026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.5bded04a-d848-4ac6-b7c3-ff9b9fef3d292026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECardinal Health 107, LLC5ba67321-6988-46ea-97a0-549954e2c4052026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEMajor Pharmaceuticals709d79a1-2742-4629-af43-161be166833a2026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.9eb6b0d1-b301-4847-88f5-f8613d550ecc2026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPD-Rx Pharmaceuticals, Inc.b6f0b2e2-3cbd-4564-8b3e-f811589af2752026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.2a7300d3-95e3-427e-bf37-55fa654cc90a2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.3d69af75-7615-4ec2-b7ef-467b2558c5c82026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.a4c525da-c2f6-b804-af49-6012959222542026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.ad350abc-a1fc-4be4-b2be-c629121552a02026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.b513823d-927c-4111-8766-e6c37f84b2212026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.68de2a51-69b2-4d99-be79-36a95a4bc4752026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEMajor Pharmaceuticals0ecbf540-572e-4ca4-b694-18ca1cd1c1942026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.1705bab2-a2f8-4534-b1fc-eb309cd2696b2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECamber Pharmaceuticals, Inc.c1387008-6dc4-4f1e-ae29-fa7a0f0be6842026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.8e5ef52d-315b-4055-9e52-403e6f896f242026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
olanzapineOLANZAPINEBionpharma Inc.8f485576-a4c4-45d4-816f-2e59fce9f5172026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: olanzapine
generic name: OLANZAPINE