Application 020965

Type: NDA
Sponsor: DUSA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVULAN	AMINOLEVULINIC ACID HYDROCHLORIDE	SOLUTION;TOPICAL	20%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020965-001	LEVULAN	AMINOLEVULINIC ACID HYDROCHLORIDE	20%	SOLUTION / TOPICAL		RLD, RS	1999-12-03

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N020965-001	11179574	2036-10-13	U-804	2025-05-30
N020965-001	11697028	2036-10-13	U-804	2025-05-30
N020965-001	12290700	2036-10-13	U-804	2025-05-30
N020965-001	11446512	2037-01-17	U-804	2025-05-30
N020965-001	10357567	2038-01-12	U-3163	2019-08-02
N020965-001	11077192	2038-01-12	U-3163	2021-08-11
N020965-001	11135293	2038-01-12	U-3163	2021-10-19
N020965-001	11571478	2038-01-12	U-3163	2023-06-14
N020965-001	11690914	2038-01-12	U-3163	2023-07-14
N020965-001	12296011	2038-01-12	U-3163	2025-06-06

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020965-001	LEVULAN	20%	SOLUTION / TOPICAL	RLD, RS	1999-12-03	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 191 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020965-001	11179574	2036-10-13	U-804	2025-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020965-001	11697028	2036-10-13	U-804	2025-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020965-001	12290700	2036-10-13	U-804	2025-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020965-001	11446512	2037-01-17	U-804	2025-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020965-001	10357567	2038-01-12	U-3163	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020965-001	11077192	2038-01-12	U-3163	2021-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020965-001	11135293	2038-01-12	U-3163	2021-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020965-001	11571478	2038-01-12	U-3163	2023-06-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020965-001	11690914	2038-01-12	U-3163	2023-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020965-001	12296011	2038-01-12	U-3163	2025-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020965-001	11179574	2036-10-13	U-804	2025-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020965-001	11697028	2036-10-13	U-804	2025-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020965-001	12290700	2036-10-13	U-804	2025-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020965-001	11446512	2037-01-17	U-804	2025-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020965-001	10357567	2038-01-12	U-3163	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020965-001	11077192	2038-01-12	U-3163	2021-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020965-001	11135293	2038-01-12	U-3163	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020965-001	11571478	2038-01-12	U-3163	2023-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020965-001	11690914	2038-01-12	U-3163	2023-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020965-001	12296011	2038-01-12	U-3163	2025-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020965-001	11179574	2036-10-13	U-804	2025-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020965-001	11697028	2036-10-13	U-804	2025-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020965-001	12290700	2036-10-13	U-804	2025-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020965-001	11446512	2037-01-17	U-804	2025-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020965-001	10357567	2038-01-12	U-3163	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020965-001	11077192	2038-01-12	U-3163	2021-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020965-001	11135293	2038-01-12	U-3163	2021-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020965-001	11571478	2038-01-12	U-3163	2023-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020965-001	11690914	2038-01-12	U-3163	2023-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020965-001	12296011	2038-01-12	U-3163	2025-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	11179574	2036-10-13	U-804	2025-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	11697028	2036-10-13	U-804	2025-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	12290700	2036-10-13	U-804	2025-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	11446512	2037-01-17	U-804	2025-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	10357567	2038-01-12	U-3163	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	11077192	2038-01-12	U-3163	2021-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	11135293	2038-01-12	U-3163	2021-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	11571478	2038-01-12	U-3163	2023-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	11690914	2038-01-12	U-3163	2023-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020965-001	12296011	2038-01-12	U-3163	2025-06-06	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020965-001	I-766	2021-03-09	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N020965-001	I-766	2021-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020965-001	I-766	2021-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020965-001	I-766	2021-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020965-001	I-766	2021-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020965-001	I-766	2021-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020965-001	I-766	2021-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020965-001	I-766	2021-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020965-001	I-766	2021-03-09	`ea99ee380514…`

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
LEVULAN KERASTICK	AMINOLEVULINIC ACID HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc	e45cc371-9ebc-4904-12bc-65cb4e2817ad	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020965 application number: NDA020965 ndc (product): 67308-101

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67308-101	LEVULAN KERASTICK	aminolevulinic acid hydrochloride	DUSA Pharmaceuticals, Inc.	NDA	Current
67308-101	LEVULAN KERASTICK	aminolevulinic acid hydrochloride	DUSA Pharmaceuticals, Inc.	NDA	Current
67308-101	LEVULAN KERASTICK	aminolevulinic acid hydrochloride	DUSA Pharmaceuticals, Inc.	NDA	Current
67308-101	LEVULAN KERASTICK	aminolevulinic acid hydrochloride	DUSA Pharmaceuticals, Inc.	NDA	Current
67308-101	LEVULAN KERASTICK	aminolevulinic acid hydrochloride	DUSA Pharmaceuticals, Inc.	NDA	Current
67308-101	LEVULAN KERASTICK	aminolevulinic acid hydrochloride	DUSA Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71045	SUPPL	2022-05-11
71031	SUPPL	2022-05-10
53784	SUPPL	2018-04-23
53749	SUPPL	2018-04-20
52913	SUPPL	2018-03-12
52872	SUPPL	2018-03-08
3856	SUPPL	2010-03-18
13821	SUPPL	2010-03-17
3855	SUPPL	2009-11-20
13820	SUPPL	2009-07-23
3854	SUPPL	2003-07-28
35724	SUPPL	2003-07-08
26304	SUPPL	2003-07-06
35723	SUPPL	2003-03-28
26303	SUPPL	2003-03-28
35722	ORIG	1999-12-07
21304	ORIG	1999-12-07
3853	ORIG	1999-12-07