Application 220418

Type: ANDA
Sponsor: NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A220418-001	SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	500MG	TABLET / ORAL	AB		2026-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A220418-001	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	A220418-001	SODIUM PHENYLBUTYRATE	500MG	TABLET / ORAL	AB		2026-02-17	`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	A220418-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium phenylbutyrate	SODIUM PHENYLBUTYRATE	Navinta LLC	c564778d-b285-4d1d-a641-9d4ee76079cf	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 220418 application number: ANDA220418
Sodium phenylbutyrate	SODIUM PHENYLBUTYRATE	Zydus Pharmaceuticals USA Inc.	d08fd548-7eb8-4f6f-b664-b0fff6f30065	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 220418 application number: ANDA220418