Application 022259

Type: NDA
Sponsor: HILL DERMACEUTICALS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOLAK	FLUOROURACIL	CREAM;TOPICAL	4%	Yes	Yes

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

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
N022259-001	TOLAK	FLUOROURACIL	4%	CREAM / TOPICAL		RLD, RS	2015-09-18

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOLAK	FLUOROURACIL	HILL DERMACEUTICALS, INC.	59de2709-00b8-4f0a-867c-f0dfeb947192	2022-09-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022259 application number: NDA022259 ndc (product): 28105-421

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
28105-421	TOLAK	FLUOROURACIL	HILL DERMACEUTICALS, INC.	NDA	Current
28105-421	TOLAK	FLUOROURACIL	HILL DERMACEUTICALS, INC.	NDA	Current
28105-421	TOLAK	FLUOROURACIL	HILL DERMACEUTICALS, INC.	NDA	Current
64370-421	TOLAK	FLUOROURACIL	Pierre Fabre Pharmaceuticals, Inc.	NDA	Current
64370-421	TOLAK	FLUOROURACIL	Pierre Fabre Pharmaceuticals, Inc.	NDA	Current
64370-421	TOLAK	FLUOROURACIL	Pierre Fabre Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72011	SUPPL	2022-09-02
71990	SUPPL	2022-09-01
46064	ORIG	2016-10-26
46063	ORIG	2016-10-26
38457	ORIG	2015-09-23
29486	ORIG	2015-09-22