Application 207096

Type: ANDA
Sponsor: AILEX PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	SOLUTION;INTRAVENOUS	10%;10% (5GM/50ML;5GM/50ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207096-001	AP

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.

Product history page 1 of 2 · 42 observed 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
2026-08-18 06:07:40	2026-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207096-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207096-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207096-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207096-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207096-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207096-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207096-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207096-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207096-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207096-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207096-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207096-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207096-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207096-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207096-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207096-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207096-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207096-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207096-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207096-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207096-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207096-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207096-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207096-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207096-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207096-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207096-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207096-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207096-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207096-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207096-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207096-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207096-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207096-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207096-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207096-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207096-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207096-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207096-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207096-001	AP	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM PHENYLACETATE and SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	Omnivium Pharmaceuticals LLC	8fafc39b-69db-40f3-8a09-ee859e8cef19	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207096 application number: ANDA207096
SODIUM PHENYLACETATE and SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	Ailex Pharmaceuticals, LLC	329655ae-c3c0-46b2-a925-e49777f2076b	2025-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207096 application number: ANDA207096 ndc (product): 70556-100
SODIUM PHENYLACETATE and SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	Omnivium Pharmaceuticals LLC	9067c301-74f9-457a-9b0f-b7e9b06a3508	2025-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207096 application number: ANDA207096

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-705	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Trigen Laboratories, LLC	ANDA	Current
13811-705	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Trigen Laboratories, LLC	ANDA	Current
13811-705	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Trigen Laboratories, LLC	ANDA	Current
69784-810	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Woodward Pharma Services LLC	ANDA	Current
69784-810	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Woodward Pharma Services LLC	ANDA	Current
69784-811	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Woodward Pharma Services LLC	ANDA	Current
69784-811	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Woodward Pharma Services LLC	ANDA	Current
70556-100	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Ailex Pharmaceuticals, LLC	ANDA	Current
70556-100	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Ailex Pharmaceuticals, LLC	ANDA	Current
70556-100	SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	Ailex Pharmaceuticals, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40582	ORIG	2016-03-04
32844	ORIG	2016-02-26