Application 077993

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLANZAPINE	OLANZAPINE	TABLET; ORAL	5MG	No	No

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 4 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Qilu Pharmaceutical Co., Ltd.	12ce860a-6f22-4db6-8acf-786b40f5a5a5	2025-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	American Health Packaging	75616c31-8fed-4014-a9f2-4a028eccd586	2025-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	40187874-447a-de20-e063-6394a90aafe7	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	3ed78a7d-4014-d280-e063-6294a90a8ee9	2025-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Preferred Pharmaceuticals Inc.	cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine Intramuscular	OLANZAPINE	PAI Holdings, LLC dba PAI Pharma	9d9f25d5-4513-434a-a37a-392a0c978f2e	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	37c88965-c51d-946d-e063-6394a90a012c	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	1866a03c-eac9-44a1-8f33-7dc6e8a8c06a	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	3c9963b1-c498-48a0-a3a1-1eaa6a1028fc	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	f6fd7ceb-1457-4c3e-9d30-4f658f39d37d	2025-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	c47f90fc-49fe-4f60-9da8-1365a1650dd9	2025-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	dcf8fcbf-636c-41ad-8084-c65ac2f117cc	2025-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	8586e828-34e7-4eb4-a933-6c688927478f	2025-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	d5a9f78e-56f4-4249-800c-5f52a99fa84b	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	d3857220-d9ff-4820-bf53-f2384b59a1a6	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	ed93d6b9-912a-444a-a695-439d0bfb877a	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Golden State Medical Supply, Inc.	9847a0e4-24fc-f4e8-e053-2995a90a961e	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Coupler LLC	325d5d69-5133-79ea-e063-6294a90afdd0	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Jubilant Cadista Pharmacuticals Inc.	028aa88e-fa50-7aa8-cc0b-97c0c9a0357c	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Cadila Pharmaceuticals Limited	2ae07ad4-4e58-4740-9f02-035ec061fefc	2025-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE

Reported adverse events (FAERS/openFDA)#

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