Application 219878

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BAXFENDY	BAXDROSTAT	TABLET; ORAL	1MG	No	No
002	BAXFENDY	BAXDROSTAT	TABLET; ORAL	2MG	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
N219878-001	BAXFENDY	BAXDROSTAT	1MG	TABLET / ORAL		RLD	2026-05-15
N219878-002	BAXFENDY	BAXDROSTAT	2MG	TABLET / ORAL		RLD, RS	2026-05-15

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219878-001	9353081	2033-02-04		Drug substance, Drug product	2026-06-04
N219878-002	9353081	2033-02-04		Drug substance, Drug product	2026-06-04

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219878-001	NCE	2031-05-15
N219878-002	NCE	2031-05-15

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	N219878-001	BAXFENDY	1MG	TABLET / ORAL		RLD	2026-05-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219878-002	BAXFENDY	2MG	TABLET / ORAL		RLD, RS	2026-05-15	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219878-001	9353081	2033-02-04		Drug substance, Drug product	2026-06-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219878-002	9353081	2033-02-04		Drug substance, Drug product	2026-06-04	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219878-001	NCE	2031-05-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219878-002	NCE	2031-05-15	`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
BAXFENDY	BAXDROSTAT	AstraZeneca Pharmaceuticals LP	b1fc1ee7-facc-4099-b3db-a4c1daeaa4be	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219878 application number: NDA219878

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85982	ORIG	2026-05-19