Application 205742

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	LIQUID;ORAL	1.1GRAMS/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
A205742-001	GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL	AA		2021-12-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205742-001	AA

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A205742-001	PC	2026-04-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL	AA	2021-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL	AA	2021-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL	AA	2021-12-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL		2021-12-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205742-001	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL	AA	2021-12-02	`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	A205742-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205742-001	AA	1	`31067a03dcf5…`
2021-12-28 21:50 UTC	2021-12	A205742-001	AA	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205742-001	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205742-001	PC	2026-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205742-001	PC	2026-04-15	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205742-001	PC	2026-04-15	`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
Glycerol Phenylbutyrate	GLYCEROL PHENYLBUTYRATE ORAL	Par Health USA, LLC	e78f2dfd-fb39-4e4b-a639-64591d282ca6	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205742 application number: ANDA205742

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69847	ORIG	2022-01-12