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 3 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEHEC Pharm USA Inc.4d1b83db-54db-d51f-e063-6394a90a4a692026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OLANZAPINEOLANZAPINEHEC Pharm USA Inc.4d34f8f3-edc8-0a68-e063-6394a90a9c1f2026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLANZAPINE
generic name: OLANZAPINE
OlanzapineOLANZAPINEDr.Reddy's Laboratories Limitedaff02cff-d079-bc82-6182-a24c4c6e09a62026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEDr. Reddy's Laboratories Inc.d474d5a9-d338-511d-5823-567c0a1bbf4d2026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OLANZAPINEOLANZAPINEAnthea Pharma Private Limitede6ffcc56-63f9-4b12-a07a-c6177ffef5e82026-03-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLANZAPINE
generic name: OLANZAPINE
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limited8e095987-bdea-42f2-9550-c7155cf07d302026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limiteddf43938a-3469-40eb-8166-f0a2fd29d6d82026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OLANZAPINEOLANZAPINETorrent Pharmaceuticals Limited2cb1bebe-0ced-46d8-bf21-c28a9acc4a152026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLANZAPINE
generic name: OLANZAPINE
OlanzapineOLANZAPINEAmerican Regent, Inc.e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee2026-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINETeva Pharmaceuticals USA, Inc.dd0b2525-4e2f-44fc-9302-0ae4ebb1e1352026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINESandoz Incc44a96cc-817d-4eb5-a13a-00977f76e6662026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEAmerican Health Packagingc0d705bf-b719-4c7b-b83d-c17d41cbbfad2026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINESandoz Inc1e9666ef-4271-4834-8496-ccb3125d83db2026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OLANZAPINEOLANZAPINEEugia US LLC9c745e2e-89d3-44d4-906e-704705c333102026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLANZAPINE
generic name: OLANZAPINE
ZyprexaOLANZAPINEH2-Pharma LLCb418946a-1ab4-4d89-a012-d94fc361a3c42026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEAurobindo Pharma Limited636665be-9d7e-443a-8134-e8cc47e6ba242026-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC495efc49-7cdb-4b9e-e063-6394a90a547e2026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEAscend Laboratories, LLCe8626e68-088d-47ff-bf06-489a778815aa2025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEApotex Corp.3347d1c8-04c9-5ce1-8cda-b38e0412b7092025-11-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC42d9ad47-52cc-ad11-e063-6394a90aedca2025-11-05Boxed 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.