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 43.

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219878-001	BAXFENDY	1MG	TABLET / ORAL	RLD	2026-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219878-002	BAXFENDY	2MG	TABLET / ORAL	RLD, RS	2026-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219878-001	BAXFENDY	1MG	TABLET / ORAL	RLD	2026-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219878-002	BAXFENDY	2MG	TABLET / ORAL	RLD, RS	2026-05-15	`caaa826d4ba7…`
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	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219878-001	9353081	2033-02-04	Drug substance, Drug product	2026-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219878-002	9353081	2033-02-04	Drug substance, Drug product	2026-06-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219878-001	9353081	2033-02-04	Drug substance, Drug product	2026-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219878-002	9353081	2033-02-04	Drug substance, Drug product	2026-06-04	`caaa826d4ba7…`
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
2026-09-14 22:38:34	2026-08	N219878-001	NCE	2031-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219878-002	NCE	2031-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219878-001	NCE	2031-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219878-002	NCE	2031-05-15	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

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