Application 211072

Type: ANDA
Sponsor: UBI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLANZAPINE	OLANZAPINE	POWDER;INTRAMUSCULAR	10MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211072-001	OLANZAPINE	OLANZAPINE	10MG/VIAL	POWDER / INTRAMUSCULAR	AP		2025-06-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A211072-001	AP

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211072-001	OLANZAPINE	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	2025-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211072-001	OLANZAPINE	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	2025-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211072-001	OLANZAPINE	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	2025-06-11	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211072-001	OLANZAPINE	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	2025-06-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211072-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211072-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211072-001	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211072-001	AP	1	`a50c72e98297…`

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	XGen Pharmaceuticals DJB, Inc.	3aad0f7b-8d0c-a9bf-e063-6394a90a6ae8	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211072 application number: ANDA211072
Olanzapine Intramuscular	OLANZAPINE	UBI Pharma Inc.	6a279fe1-ed99-4a62-b2c7-831961470fa9	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211072 application number: ANDA211072
Olanzapine Intramuscular	OLANZAPINE	PAI Holdings, LLC dba PAI Pharma	9d9f25d5-4513-434a-a37a-392a0c978f2e	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211072 application number: ANDA211072