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 5 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	NCS HealthCare of KY, LLC dba Vangard Labs	87b7fb23-c9b7-433f-bd17-cd3e91714c27	2025-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Direct_Rx	fcec190f-b865-c5d3-e053-6394a90a7e45	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Direct_Rx	22528ae1-e36f-48e1-e063-6294a90a3dd2	2024-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	NorthStar RxLLC	ea3259d5-36ee-4ac9-b849-9625626e2187	2024-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Qilu Pharmaceutical Co., Ltd.	6077f5c4-01d7-4c1d-97a0-cb859f98ce68	2024-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	024e8e9b-a4fc-4882-b080-c070467166a6	2024-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	NorthStar RxLLC	f4e41c2c-d32d-40c2-8afb-b6df998ba6b0	2023-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Lannett Company, Inc.	002dd00f-7946-ea4f-e063-6294a90a5916	2023-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	09e48e71-4dd2-4538-91d7-5b284f6647d8	2023-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	ce66d545-015b-41d5-80c3-964d78e36bfd	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Ltd.	9a57a63e-f856-aafa-037a-c08f2fea6496	2022-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	e40d54bf-7334-4418-8a87-ff85941adec1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	61424fa3-b09a-4267-a208-a7c7c3f69fe5	2020-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Aphena Pharma Solutions - Tennessee, LLC	b6ec5610-b4a6-4646-954a-0fe8b1d3e143	2020-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	7772a4c2-1fb1-412b-9e3b-ef3d693517a2	2019-11-01	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.