Application 020450

Type: NDA
Sponsor: PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEREBYX	FOSPHENYTOIN SODIUM	INJECTABLE;INJECTION	EQ 50MG PHENYTOIN NA/ML	Yes	Yes

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
N020450-001	CEREBYX	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020450-001	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	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020450-001	CEREBYX	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	RLD, RS	1996-08-05	`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	N020450-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020450-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020450-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020450-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020450-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020450-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020450-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020450-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020450-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020450-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020450-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020450-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020450-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020450-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020450-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020450-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020450-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020450-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020450-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020450-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020450-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020450-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020450-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020450-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020450-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020450-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020450-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020450-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020450-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020450-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020450-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020450-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020450-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020450-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020450-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020450-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020450-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020450-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020450-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020450-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEREBYX	FOSPHENYTOIN SODIUM	Pfizer Laboratories Div Pfizer Inc	d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020450 application number: NDA020450 ndc (product): 0069-6001
CEREBYX	FOSPHENYTOIN SODIUM	Pfizer Laboratories Div Pfizer Inc	de5a6711-4abb-4c3d-a18b-266b094ace11	2025-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020450 application number: NDA020450 ndc (product): 0069-5471 ndc (product): 0069-5474

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-5471	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5471	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5471	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5471	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5471	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5471	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5471	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5471	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5471	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5474	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5474	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5474	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5474	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5474	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5474	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5474	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5474	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-5474	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-6001	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-6001	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-6001	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-6001	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-6001	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-6001	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-6001	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-6001	CEREBYX	Fosphenytoin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70854	SUPPL	2022-04-29
69477	SUPPL	2021-12-06
69476	SUPPL	2021-12-06
66276	SUPPL	2021-02-18
66250	SUPPL	2021-02-17
61734	SUPPL	2020-01-29
61715	SUPPL	2020-01-29
59338	SUPPL	2019-07-16
59336	SUPPL	2019-07-15
50311	SUPPL	2017-11-06
50310	SUPPL	2017-11-06
50258	SUPPL	2017-11-01
50257	SUPPL	2017-11-01
47570	SUPPL	2017-03-16
47554	SUPPL	2017-03-14
47396	SUPPL	2017-03-02
47387	SUPPL	2017-03-02
45833	SUPPL	2016-11-08
45825	SUPPL	2016-11-07
34673	SUPPL	2016-06-21
34672	SUPPL	2016-03-04
2556	SUPPL	2016-03-04
34671	SUPPL	2015-06-10
24990	SUPPL	2015-06-10
24989	SUPPL	2014-06-17
12601	SUPPL	2014-06-17
24988	SUPPL	2014-01-07
12600	SUPPL	2014-01-07
34670	SUPPL	2013-11-20
2555	SUPPL	2013-10-24
34669	SUPPL	2013-03-08
24987	SUPPL	2013-03-08
24986	SUPPL	2011-11-17
24985	SUPPL	2011-11-17
2554	SUPPL	2011-11-17
2553	SUPPL	2011-11-17
34668	SUPPL	2011-11-16
34667	SUPPL	2011-11-16
12599	SUPPL	2011-11-16
12598	SUPPL	2011-11-16
20665	SUPPL	2007-05-30
41376	SUPPL	2007-05-29
41375	SUPPL	2003-06-17
34666	SUPPL	2003-04-25
12597	SUPPL	2001-08-31
57444	ORIG	1997-04-11
51131	SUPPL	1900-01-01
51130	SUPPL	1900-01-01
51129	SUPPL	1900-01-01