Application 215947

Type: ANDA
Sponsor: ONCOGEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	TABLET;ORAL	250MG	No	No
002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	TABLET;ORAL	500MG	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
A215947-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2022-01-05
A215947-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2022-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215947-001	AB
A215947-002	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
2026-08-01 22:54:32	2026-06	A215947-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2022-01-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A215947-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2022-01-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A215947-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A215947-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Abiraterone Acetate	ABIRATERONE ACETATE	Novugen Pharma (USA) LLC	f308b463-27e4-422a-95a2-ecbbf95eee20	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215947 application number: ANDA215947 ndc (product): 82293-002 ndc (product): 82293-001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-9429	Abiraterone Acetate	abiraterone acetate	Bryant Ranch Prepack	ANDA	Current
63629-9430	Abiraterone Acetate	abiraterone acetate	Bryant Ranch Prepack	ANDA	Current
82293-001	Abiraterone Acetate	abiraterone acetate	Novugen Pharma (USA) LLC	ANDA	Current
82293-002	Abiraterone Acetate	abiraterone acetate	Novugen Pharma (USA) LLC	ANDA	Current