Application 208081

Type: NDA
Sponsor: BIOFRONTERA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMELUZ	AMINOLEVULINIC ACID HYDROCHLORIDE	GEL;TOPICAL	10%	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
N208081-001	AMELUZ	AMINOLEVULINIC ACID HYDROCHLORIDE	10%	GEL / TOPICAL		RLD, RS	2016-05-10

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208081-001	11540981	2028-02-07		Drug product	2023-01-18
N208081-001	11235169	2040-10-15	U-3303		2022-02-23
N208081-001	12280146	2043-12-08		Drug product	2025-05-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208081-001	D-194	2027-10-04

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208081-001	AMELUZ	10%	GEL / TOPICAL	RLD, RS	2016-05-10	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208081-001	12280146	2043-12-08		Drug product	2025-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208081-001	12280146	2043-12-08		Drug product	2025-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208081-001	12280146	2043-12-08		Drug product	2025-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208081-001	12280146	2043-12-08		Drug product	2025-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208081-001	11540981	2028-02-07		Drug product	2023-01-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208081-001	11235169	2040-10-15	U-3303		2022-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208081-001	6559183	2019-11-12	U-804	Drug product	2016-10-07	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208081-001	6559183	2019-11-12	U-804	Drug product	2016-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208081-001	6559183	2019-11-12	U-804	Drug product	2016-10-07	`b00525d2431f…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N208081-001	D-194	2027-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208081-001	D-194	2027-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208081-001	D-194	2027-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208081-001	D-194	2027-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208081-001	D-194	2027-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208081-001	D-194	2027-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208081-001	D-194	2027-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208081-001	D-194	2027-10-04	`2680178bc6a6…`
2019-12-13 00:20 UTC	2019-12	N208081-001	NP	2019-05-10	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208081-001	NP	2019-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208081-001	NP	2019-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208081-001	NP	2019-05-10	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208081-001	D-194	2027-10-04	`a50c72e98297…`

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
AMELUZ	AMINOLEVULINIC ACID HYDROCHLORIDE	Biofrontera Inc.	650daa9f-aeec-49ce-95b9-5fa20b988afd	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208081 application number: NDA208081 ndc (product): 70621-101

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current
70621-101	AMELUZ	aminolevulinic acid hydrochloride	Biofrontera Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79830	SUPPL	2024-10-07
79824	SUPPL	2024-10-07
77868	SUPPL	2024-03-19
77859	SUPPL	2024-03-18
67605	SUPPL	2021-05-27
67599	SUPPL	2021-05-26
49702	SUPPL	2017-09-08
49683	SUPPL	2017-09-07
47165	ORIG	2017-02-10
10643	ORIG	2016-05-16
19984	ORIG	2016-05-11