Application 218645

Type: ANDA
Sponsor: AUCTA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	POWDER;ORAL	100MG/PACKET	No	No
002	ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	POWDER;ORAL	500MG/PACKET	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
A218645-001	ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	FOR SOLUTION / ORAL	AB		2025-04-29
A218645-002	ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	FOR SOLUTION / ORAL	AB		2025-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218645-001	AB
A218645-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218645-001	ZELVYSIA	100MG/PACKET	POWDER / ORAL	AB	2025-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218645-002	ZELVYSIA	500MG/PACKET	POWDER / ORAL	AB	2025-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218645-001	ZELVYSIA	100MG/PACKET	POWDER / ORAL	AB	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218645-002	ZELVYSIA	500MG/PACKET	POWDER / ORAL	AB	2025-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218645-001	ZELVYSIA	100MG/PACKET	POWDER / ORAL	AB	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218645-002	ZELVYSIA	500MG/PACKET	POWDER / ORAL	AB	2025-04-29	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218645-001	ZELVYSIA	100MG/PACKET	FOR SOLUTION / ORAL	AB	2025-04-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218645-002	ZELVYSIA	500MG/PACKET	FOR SOLUTION / ORAL	AB	2025-04-29	`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	A218645-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218645-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218645-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218645-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218645-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218645-002	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218645-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218645-002	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
ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	Aucta Pharmaceuticals, Inc.	8de84882-dd24-46f2-8416-5e492d4275d1	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218645 application number: ANDA218645