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 5 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINENCS HealthCare of KY, LLC dba Vangard Labs87b7fb23-c9b7-433f-bd17-cd3e91714c272025-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEDirect_Rxfcec190f-b865-c5d3-e053-6394a90a7e452025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEDirect_Rx22528ae1-e36f-48e1-e063-6294a90a3dd22024-09-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINENorthStar RxLLCea3259d5-36ee-4ac9-b849-9625626e21872024-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEQilu Pharmaceutical Co., Ltd.6077f5c4-01d7-4c1d-97a0-cb859f98ce682024-06-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LP024e8e9b-a4fc-4882-b080-c070467166a62024-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINENorthStar RxLLCf4e41c2c-d32d-40c2-8afb-b6df998ba6b02023-10-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINELannett Company, Inc.002dd00f-7946-ea4f-e063-6294a90a59162023-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepack09e48e71-4dd2-4538-91d7-5b284f6647d82023-03-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LPce66d545-015b-41d5-80c3-964d78e36bfd2023-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.9a57a63e-f856-aafa-037a-c08f2fea64962022-10-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LP1f4a2eaf-3a12-4ebe-b97f-0a7bfbc325722022-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LPe40d54bf-7334-4418-8a87-ff85941adec12021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LP61424fa3-b09a-4267-a208-a7c7c3f69fe52020-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEAphena Pharma Solutions - Tennessee, LLCb6ec5610-b4a6-4646-954a-0fe8b1d3e1432020-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LP7772a4c2-1fb1-412b-9e3b-ef3d693517a22019-11-01Boxed 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.