Application 211527

Type: NDA
Sponsor: GALDERMA R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AKLIEF	TRIFAROTENE	CREAM;TOPICAL	0.005%	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
N211527-001	AKLIEF	TRIFAROTENE	0.005%	CREAM / TOPICAL		RLD, RS	2019-10-04

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
N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31
N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31
N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17

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
2026-09-14 22:38:34	2026-08	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211527-001	AKLIEF	0.005%	CREAM / TOPICAL	RLD, RS	2019-10-04	`cb3db0bc1861…`

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	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211527-001	8227507	2025-12-21	U-818		2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211527-001	8470871	2025-12-21	U-2639		2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211527-001	8227507	2025-12-21	U-818		2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211527-001	8470871	2025-12-21	U-2639		2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211527-001	8227507	2025-12-21	U-818		2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211527-001	8470871	2025-12-21	U-2639		2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211527-001	8227507	2025-12-21	U-818		2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211527-001	8470871	2025-12-21	U-2639		2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211527-001	8227507	2025-12-21	U-818		2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211527-001	8470871	2025-12-21	U-2639		2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211527-001	8227507	2025-12-21	U-818		2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211527-001	8470871	2025-12-21	U-2639		2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211527-001	7807708	2031-07-19		Drug substance, Drug product	2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211527-001	9084778	2033-05-30	U-134	Drug product	2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211527-001	9498465	2033-05-30	U-1033	Drug product	2021-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211527-001	8227507	2025-12-21	U-818		2019-10-31	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211527-001	NCE	2024-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211527-001	NCE	2024-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211527-001	NCE	2024-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211527-001	NCE	2024-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211527-001	NCE	2024-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211527-001	NCE	2024-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211527-001	NCE	2024-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211527-001	NCE	2024-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211527-001	NCE	2024-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211527-001	NCE	2024-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211527-001	NCE	2024-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211527-001	NCE	2024-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211527-001	NCE	2024-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211527-001	NCE	2024-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211527-001	NCE	2024-10-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211527-001	NCE	2024-10-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211527-001	NCE	2024-10-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211527-001	NCE	2024-10-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211527-001	NCE	2024-10-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211527-001	NCE	2024-10-04	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211527-001	NCE	2024-10-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211527-001	NCE	2024-10-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211527-001	NCE	2024-10-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211527-001	NCE	2024-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211527-001	NCE	2024-10-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211527-001	NCE	2024-10-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211527-001	NCE	2024-10-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211527-001	NCE	2024-10-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211527-001	NCE	2024-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211527-001	NCE	2024-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211527-001	NCE	2024-10-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211527-001	NCE	2024-10-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211527-001	NCE	2024-10-04	`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
AKLIEF	TRIFAROTENE	Galderma Laboratories, L.P.	62d910db-85a6-4696-b69b-4bd2f3080cfc	2024-09-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211527 application number: NDA211527 ndc (product): 0299-5935

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-5935	AKLIEF	trifarotene	Galderma Laboratories, L.P.	NDA	Current
0299-5935	AKLIEF	trifarotene	Galderma Laboratories, L.P.	NDA	Current
0299-5935	AKLIEF	trifarotene	Galderma Laboratories, L.P.	NDA	Current
0299-5935	AKLIEF	trifarotene	Galderma Laboratories, L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71609	SUPPL	2022-07-20
71607	SUPPL	2022-07-20
60613	ORIG	2019-10-21
60596	ORIG	2019-10-08
60595	ORIG	2019-10-08
63272	ORIG	1900-01-01