FDA.reportPublic FDA data

Application 077993

Type
ANDA
Sponsor
ROXANE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINETABLET; ORAL5MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEUnit Dose Solutions, Inc.55668be2-62ac-3252-e063-6394a90a40f72026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.e830f488-c689-40f6-9351-f9c7454ff1ea2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINERedpharm Drug54adae9e-6781-6a77-e063-6394a90ab5c82026-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC549dc142-adcd-99ed-e063-6294a90a37fa2026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC53e6b4e9-de26-16c3-e063-6294a90a77642026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.032e589c-47b1-4eb1-9466-8160297b81e92026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEAurobindo Pharma Limited4d768cfe-3b20-4127-95b9-b4151b28afcc2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC52b99337-afa8-a6f9-e063-6294a90a20382026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC52bdaaaf-ab54-99d1-e063-6394a90a521f2026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepack4e90e30c-78a1-486f-a13c-f1ff798216be2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC51b508ff-dc55-ff36-e063-6294a90a900f2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC51b64b6d-4676-a637-e063-6394a90a450c2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC518a9400-edb8-6403-e063-6294a90a065d2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.a1dfb4e7-4143-4422-b7a7-292e4fd750442026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OLANZAPINEOLANZAPINEGLENMARK PHARMACEUTICALS INC., USA2e709eaf-4116-4ee3-8dff-ace36181d1152026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLANZAPINE
generic name: OLANZAPINE
OlanzapineOLANZAPINEModavar Pharmaceuticals LLCf0943b4e-6bdc-48c1-8ecd-39cf732e16f52026-04-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEXGen Pharmaceuticals DJB, Inc.3aad0f7b-8d0c-a9bf-e063-6394a90a6ae82026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEStrides Pharma Science Limited979c3212-36e8-4287-aace-bef0875188d72026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.76a6ff21-7157-4213-8073-35837a3ac07e2026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
Olanzapine IntramuscularOLANZAPINEUBI Pharma Inc.6a279fe1-ed99-4a62-b2c7-831961470fa92026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE

Reported adverse events (FAERS/openFDA)#

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