Application 016831

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EFUDEX	FLUOROURACIL	SOLUTION;TOPICAL	2%	Yes	Yes
002	EFUDEX	FLUOROURACIL	SOLUTION;TOPICAL	5%	Yes	Yes
003	EFUDEX	FLUOROURACIL	CREAM;TOPICAL	5%	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N016831-001	EFUDEX	FLUOROURACIL	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982
N016831-002	EFUDEX	FLUOROURACIL	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982
N016831-003	EFUDEX	FLUOROURACIL	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N016831-001	AT
N016831-003	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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016831-002	EFUDEX	5%	SOLUTION / TOPICAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016831-002	EFUDEX	5%	SOLUTION / TOPICAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016831-002	EFUDEX	5%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016831-002	EFUDEX	5%	SOLUTION / TOPICAL		RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016831-002	EFUDEX	5%	SOLUTION / TOPICAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016831-002	EFUDEX	5%	SOLUTION / TOPICAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016831-002	EFUDEX	5%	SOLUTION / TOPICAL		RLD, Approved before 1982	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	N016831-001	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016831-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016831-001	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016831-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016831-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016831-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016831-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016831-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016831-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016831-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016831-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016831-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016831-001	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016831-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016831-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016831-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016831-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016831-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016831-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016831-003	AB	1	`4b0b4de00fa7…`

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
Efudex	FLUOROURACIL	Bausch Health US, LLC	35de1c1c-bef5-46c5-b6f8-ea032147411c	2025-04-23		Exact identifier application applno (NDA): 016831 application number: NDA016831 ndc (product): 0187-3204
Fluorouracil	FLUOROURACIL	Mylan Pharmaceuticals Inc.	744737c5-0d96-4214-82ab-6cff016b1ea0	2021-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016831 application number: NDA016831 ndc (product): 0378-4791

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-3204	Efudex	Fluorouracil	Bausch Health Americas, Inc.	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US, LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US, LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US, LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US, LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US LLC	NDA	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
43547-258	Fluorouracil	Fluorouracil	Solco Healthcare US LLC	NDA	Current
43547-259	Fluorouracil	Fluorouracil	Solco Healthcare US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69018	SUPPL	2021-10-19
68998	SUPPL	2021-10-15
40731	SUPPL	2011-06-23
40730	SUPPL	2011-06-23
40729	SUPPL	2011-06-23
40728	SUPPL	2011-06-23
20067	SUPPL	2011-06-23
20066	SUPPL	2011-06-23
503	SUPPL	2006-05-16
10926	SUPPL	2005-10-19
502	SUPPL	2005-10-19
33201	SUPPL	2004-06-25
501	SUPPL	2004-06-25
13039	SUPPL	2004-04-29