Application 084349

Type: ANDA
Sponsor: PARKE-DAVIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILANTIN	PHENYTOIN SODIUM	CAPSULE;ORAL	30MG EXTENDED	No	Yes
002	DILANTIN	PHENYTOIN SODIUM	CAPSULE;ORAL	100MG EXTENDED	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A084349-001	DILANTIN	PHENYTOIN SODIUM	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982
A084349-002	DILANTIN	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	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
A084349-002	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 3 of 3 · 88 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
2022-10-28 04:53 UTC	2022-10	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A084349-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A084349-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084349-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084349-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084349-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084349-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084349-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084349-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084349-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084349-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084349-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084349-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084349-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084349-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084349-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084349-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084349-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084349-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084349-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084349-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084349-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084349-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084349-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084349-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084349-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084349-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084349-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084349-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084349-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084349-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084349-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084349-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084349-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084349-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084349-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084349-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084349-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084349-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084349-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084349-002	AB	1	`3a93d1ddd44b…`

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
DILANTIN	EXTENDED PHENYTOIN SODIUM	REMEDYREPACK INC.	db8c69b0-4697-433e-98c7-b0b2d2c52a83	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084349 application number: ANDA084349
DILANTIN	EXTENDED PHENYTOIN SODIUM	Viatris Specialty LLC	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	2023-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084349 application number: ANDA084349

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0071-0369	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-0369	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-0369	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-0369	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-0369	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-0369	Dilantin	Phenytoin Sodium	Parke-Davis Div of Pfizer	ANDA	Current
0071-0369	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-3740	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-3740	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-3740	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-3740	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-3740	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
0071-3740	Dilantin	Phenytoin Sodium	Parke-Davis Div of Pfizer	ANDA	Current
0071-3740	Dilantin	Extended Phenytoin Sodium	Parke-Davis Div of Pfizer Inc	ANDA	Current
43353-131	Dilantin	Phenytoin Sodium	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
50090-0029	Dilantin	Phenytoin Sodium	A-S Medication Solutions	ANDA	Current
50090-0029	Dilantin	Phenytoin Sodium	A-S Medication Solutions	ANDA	Current
68151-1019	Dilantin	Phenytoin Sodium	Carilion Materials Management	ANDA	Current
69189-3742	Dilantin	Phenytoin Sodium	Avera McKennan Hospital	ANDA	Current
70518-0980	Dilantin	Phenytoin Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0980	Dilantin	Phenytoin Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0980	Dilantin	Phenytoin Sodium	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72260	SUPPL	2022-10-06
72259	SUPPL	2022-10-06
69329	SUPPL	2021-11-16
69328	SUPPL	2021-11-16
64791	SUPPL	2020-10-02
64786	SUPPL	2020-10-01
57040	SUPPL	2018-12-27
57039	SUPPL	2018-12-27
51839	SUPPL	2018-01-26
51837	SUPPL	2018-01-26
51835	SUPPL	2018-01-26
48070	SUPPL	2017-04-19
39581	SUPPL	2015-04-23
31428	SUPPL	2015-04-23
39580	SUPPL	2014-07-29
39579	SUPPL	2014-03-06
39575	SUPPL	2014-03-06
9241	SUPPL	2014-03-06
9239	SUPPL	2014-03-06
39578	SUPPL	2013-09-19
9240	SUPPL	2013-08-08
31427	SUPPL	2012-12-06
39577	SUPPL	2012-11-30
43190	SUPPL	2012-03-28
39576	SUPPL	2011-05-06
39574	SUPPL	2009-10-19