Application 008762

Type: NDA
Sponsor: PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILANTIN-125	PHENYTOIN	SUSPENSION;ORAL	125MG/5ML	Yes	Yes
002	DILANTIN-30	PHENYTOIN	SUSPENSION;ORAL	30MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N008762-001	DILANTIN-125	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982
N008762-002	DILANTIN-30	PHENYTOIN	30MG/5ML	SUSPENSION / ORAL		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
N008762-001	AB

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N008762-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008762-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008762-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008762-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008762-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008762-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008762-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008762-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008762-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008762-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008762-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008762-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008762-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008762-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008762-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008762-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008762-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008762-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008762-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008762-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008762-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008762-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008762-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008762-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008762-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008762-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008762-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008762-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008762-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008762-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008762-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008762-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008762-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008762-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008762-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008762-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008762-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008762-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N008762-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N008762-001	AB	1	`cb3db0bc1861…`

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
Phenytoin	PHENYTOIN	Mylan Pharmaceuticals Inc.	37943ec1-a8d2-42df-967e-6f96f84c017b	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008762 application number: NDA008762 ndc (product): 59762-0531
Dilantin-125	PHENYTOIN	Viatris Specialty LLC	f339f9e4-b289-4efe-82b9-46c57d1dc277	2023-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008762 application number: NDA008762

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0071-2214	Dilantin-125	Phenytoin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-2214	Dilantin-125	Phenytoin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-2214	Dilantin-125	Phenytoin	Parke-Davis Div of Pfizer	NDA	Current
0071-2214	Dilantin-125	Phenytoin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-2214	Dilantin-125	Phenytoin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-2214	Dilantin-125	Phenytoin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-2214	Dilantin-125	Phenytoin	Parke-Davis Div of Pfizer Inc	NDA	Current
59762-0531	Phenytoin	Phenytoin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0531	Phenytoin	Phenytoin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0531	Phenytoin	Phenytoin	Greenstone LLC	NDA AUTHORIZED	Current
59762-0531	Phenytoin	Phenytoin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0531	Phenytoin	Phenytoin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0531	Phenytoin	Phenytoin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0531	Phenytoin	Phenytoin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70405	SUPPL	2022-03-07
70404	SUPPL	2022-03-07
70402	SUPPL	2022-03-07
66277	SUPPL	2021-02-18
66249	SUPPL	2021-02-17
59337	SUPPL	2019-07-16
59334	SUPPL	2019-07-15
56060	SUPPL	2018-10-23
56044	SUPPL	2018-10-19
50313	SUPPL	2017-11-06
50312	SUPPL	2017-11-06
50254	SUPPL	2017-11-01
50253	SUPPL	2017-11-01
50252	SUPPL	2017-11-01
50251	SUPPL	2017-11-01
49566	SUPPL	2017-08-29
49452	SUPPL	2017-08-17
46056	SUPPL	2016-12-06
46055	SUPPL	2016-12-06
45992	SUPPL	2016-12-01
45991	SUPPL	2016-12-01
32977	SUPPL	2016-06-21
32976	SUPPL	2016-01-26
167	SUPPL	2016-01-26
113	SUPPL	2015-04-17
32975	SUPPL	2015-04-16
32974	SUPPL	2014-04-04
112	SUPPL	2014-04-04
10709	SUPPL	2014-01-28
166	SUPPL	2014-01-28
10708	SUPPL	2013-03-08
111	SUPPL	2013-03-08
40654	SUPPL	2012-06-26
32973	SUPPL	2011-12-14
32972	SUPPL	2011-12-14
32971	SUPPL	2011-12-14
32969	SUPPL	2011-12-14
10707	SUPPL	2011-12-14
165	SUPPL	2011-12-01
164	SUPPL	2011-12-01
109	SUPPL	2011-12-01
108	SUPPL	2011-12-01
106	SUPPL	2011-12-01
110	SUPPL	2011-05-31
10706	SUPPL	2011-01-25
107	SUPPL	2011-01-24
163	SUPPL	2009-04-29
32970	SUPPL	2009-04-28
162	SUPPL	2003-03-26
161	SUPPL	2001-11-20
160	SUPPL	2001-11-20
105	SUPPL	2001-11-20
104	SUPPL	2001-11-20