Application 021112

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRI-LUMA	FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN	CREAM;TOPICAL	0.01%;4%;0.05%	Yes	Yes

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

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
N021112-001	TRI-LUMA	FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN	0.01%;4%;0.05%	CREAM / TOPICAL		RLD, RS	2002-01-18

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021112-001	TRI-LUMA	0.01%;4%;0.05%	CREAM / TOPICAL	RLD, RS	2002-01-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021112-001	TRI-LUMA	0.01%;4%;0.05%	CREAM / TOPICAL	RLD, RS	2002-01-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021112-001	TRI-LUMA	0.01%;4%;0.05%	CREAM / TOPICAL	RLD, RS	2002-01-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021112-001	TRI-LUMA	0.01%;4%;0.05%	CREAM / TOPICAL	RLD, RS	2002-01-18	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

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	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021112-001	8247395	2022-10-25	Drug product	2012-10-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021112-001	8653053	2022-10-25	Drug product	2014-03-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021112-001	7915243	2023-09-08	Drug product	2011-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021112-001	7939516	2023-09-08	Drug product	2011-05-17	`c0c555d07b60…`

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
TRI-LUMA	FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN	Galderma Laboratories, L.P.	a35fa709-5eb5-4429-b38f-f1e0019bf0ee	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021112 application number: NDA021112 ndc (product): 0299-5950

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
0299-5950	TRI-LUMA	fluocinolone acetonide, hydroquinone, and tretinoin	Galderma Laboratories, L.P.	NDA	Current
0299-5950	TRI-LUMA	fluocinolone acetonide, hydroquinone, and tretinoin	Galderma Laboratories, L.P.	NDA	Current
0299-5950	TRI-LUMA	fluocinolone acetonide, hydroquinone, and tretinoin	Galderma Laboratories, L.P.	NDA	Current
0299-5950	TRI-LUMA	fluocinolone acetonide, hydroquinone, and tretinoin	Galderma Laboratories, L.P.	NDA	Current
0299-5950	TRI-LUMA	fluocinolone acetonide, hydroquinone, and tretinoin	Galderma Laboratories, L.P.	NDA	Current
0299-5950	TRI-LUMA	fluocinolone acetonide, hydroquinone, and tretinoin	Galderma Laboratories, L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
26802	SUPPL	2014-04-02
14417	SUPPL	2014-04-01
4366	SUPPL	2013-01-28
36147	SUPPL	2013-01-22
4365	SUPPL	2012-12-26
41956	ORIG	2002-03-26
14416	ORIG	2002-01-18