Application 216068

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENZALUTAMIDE	ENZALUTAMIDE	TABLET;ORAL	40MG	No	No
002	ENZALUTAMIDE	ENZALUTAMIDE	TABLET;ORAL	80MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216068-001	ENZALUTAMIDE	ENZALUTAMIDE	40MG	TABLET / ORAL	AB		2026-04-20
A216068-002	ENZALUTAMIDE	ENZALUTAMIDE	80MG	TABLET / ORAL	AB		2026-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A216068-001	AB
A216068-002	AB

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	RLD / RS	Approval date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216068-001	ENZALUTAMIDE	40MG	TABLET / ORAL	AB		2026-04-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216068-002	ENZALUTAMIDE	80MG	TABLET / ORAL	AB		2026-04-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216068-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216068-002	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xtandi	ENZALUTAMIDE	Astellas Pharma US, Inc.	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	2026-05-26	Warnings, Adverse reactions	Name fallback generic name: ENZALUTAMIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72025	ORIG	2022-09-07