Application 220568

Type: ANDA
Sponsor: NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	LIQUID;ORAL	1.1GM/ML	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
A220568-001	GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL	AA		2026-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A220568-001	AA

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	A220568-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL	AA		2026-04-23	`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	A220568-001	AA	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
Glycerol Phenylbutyrate	GLYCEROL PHENYLBUTYRATE	Navinta LLC	15c4da9f-f5e0-4628-b55f-3730be3e1c39	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 220568 application number: ANDA220568
Glycerol Phenylbutyrate	GLYCEROL PHENYLBUTYRATE	Zydus Pharmaceuticals USA Inc.	c094cb63-3aa0-4564-9c53-7e78f2a56367	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 220568 application number: ANDA220568