Application 084307

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENYTOIN SODIUM	PHENYTOIN SODIUM	INJECTABLE;INJECTION	50MG/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A084307-001	PHENYTOIN SODIUM	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084307-001	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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A084307-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084307-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084307-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084307-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084307-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084307-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084307-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084307-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084307-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084307-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084307-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084307-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084307-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084307-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084307-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084307-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084307-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084307-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084307-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084307-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084307-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084307-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084307-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084307-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084307-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084307-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084307-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084307-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084307-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084307-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084307-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084307-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084307-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084307-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084307-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084307-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084307-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084307-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084307-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084307-001	AP	1	`f41ea6bd6efb…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenytoin Sodium	PHENYTOIN SODIUM	ProPharma Distribution	43060ca9-58a7-3371-e063-6294a90a5799	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307
Phenytoin Sodium	PHENYTOIN SODIUM	Henry Schein, Inc.	889dd22c-46f0-48d0-b18e-a3783c5fa653	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307 ndc (product): 0404-9932
PHENYTOIN SODIUM	PHENYTOIN SODIUM	Henry Schein, Inc.	a52cf1bd-dc1f-47be-aba8-29066d9a50fb	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307
Phenytoin Sodium	PHENYTOIN SODIUM	Hikma Pharmaceuticals USA Inc.	035a8d4e-2063-4240-83cb-d7eebcabe301	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307 ndc (product): 0641-0493 ndc (product): 0641-2555
Phenytoin Sodium	PHENYTOIN SODIUM	Hikma Pharmaceuticals USA Inc.	8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307 ndc (product): 0641-6139 ndc (product): 0641-6138
PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	7607ddff-2f1c-272c-e053-2991aa0a1ab3	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307 ndc (product): 51662-1251
Phenytoin Sodium	PHENYTOIN SODIUM	Medical Purchasing Solutions, LLC	0aac9dcd-c4df-84d9-e063-6294a90a0376	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307
PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	763b549d-9b78-09dd-e053-2a91aa0aec7f	2022-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307 ndc (product): 51662-1250

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9932	Phenytoin Sodium	Phenytoin Sodium	Henry Schein, Inc.	ANDA	Current
0404-9932	Phenytoin Sodium	Phenytoin Sodium	Henry Schein, Inc.	ANDA	Current
0404-9933	Phenytoin Sodium	Phenytoin Sodium	Henry Schein, Inc.	ANDA	Current
0404-9933	Phenytoin Sodium	Phenytoin Sodium	Henry Schein, Inc.	ANDA	Current
0641-0493	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-0493	Phenytoin Sodium	Phenytoin Sodium	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-0493	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-2555	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-2555	Phenytoin Sodium	Phenytoin Sodium	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-2555	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6138	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6138	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6138	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6138	Phenytoin Sodium	Phenytoin Sodium	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6139	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6139	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6139	Phenytoin Sodium	Phenytoin Sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6139	Phenytoin Sodium	Phenytoin Sodium	West-Ward Pharmaceuticals Corp.	ANDA	Current
51662-1250	PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1250	PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1250	PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1250	PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1251	PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1251	PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1251	PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1251	PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-493	Phenytoin Sodium	Phenytoin Sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-493	Phenytoin Sodium	Phenytoin Sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-493	Phenytoin Sodium	Phenytoin Sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-493	Phenytoin Sodium	Phenytoin Sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-555	Phenytoin Sodium	Phenytoin Sodium	General Injectables & Vaccines, Inc.	ANDA	Current
52584-555	Phenytoin Sodium	Phenytoin Sodium	General Injectables & Vaccines, Inc.	ANDA	Current
52584-555	Phenytoin Sodium	Phenytoin Sodium	General Injectables & Vaccines, Inc.	ANDA	Current
52584-555	Phenytoin Sodium	Phenytoin Sodium	General Injectables & Vaccines, Inc.	ANDA	Current
55154-5117	Phenytoin Sodium	Phenytoin Sodium	Cardinal Health	ANDA	Current
55154-5117	Phenytoin Sodium	Phenytoin Sodium	Cardinal Health	ANDA	Current