Application 012806

Type: NDA
Sponsor: ALMIRALL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORDRAN	FLURANDRENOLIDE	OINTMENT;TOPICAL	0.05%	Yes	Yes
002	CORDRAN SP	FLURANDRENOLIDE	CREAM;TOPICAL	0.05%	Yes	Yes
003	CORDRAN SP	FLURANDRENOLIDE	CREAM;TOPICAL	0.025%	Yes	Yes
004	CORDRAN	FLURANDRENOLIDE	OINTMENT;TOPICAL	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N012806-001	CORDRAN	FLURANDRENOLIDE	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982
N012806-002	CORDRAN SP	FLURANDRENOLIDE	0.05%	CREAM / TOPICAL	RLD, Approved before 1982
N012806-003	CORDRAN SP	FLURANDRENOLIDE	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982
N012806-004	CORDRAN	FLURANDRENOLIDE	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982

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 5 · 176 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012806-003	CORDRAN SP	0.025%	CREAM / TOPICAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012806-003	CORDRAN SP	0.025%	CREAM / TOPICAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012806-004	CORDRAN	0.025%	OINTMENT / TOPICAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012806-003	CORDRAN SP	0.025%	CREAM / TOPICAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012806-004	CORDRAN	0.025%	OINTMENT / TOPICAL		RLD, Approved before 1982	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012806-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012806-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012806-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012806-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012806-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012806-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012806-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012806-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012806-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012806-001	AT	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012806-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012806-001	AT	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012806-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012806-001	AT	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012806-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012806-001	AT	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012806-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012806-001	AT	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012806-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012806-001	AT	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012806-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012806-001	AT	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012806-002	AT	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	N012806-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012806-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012806-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012806-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012806-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012806-001	AT	1	`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
CORDRAN	FLURANDRENOLIDE	INA Pharmaceutics, Inc	39c0d1e6-6816-7ae5-e063-6394a90a592e	2025-07-07	Adverse reactions	Exact identifier application applno (NDA): 012806 application number: NDA012806

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16110-026	Cordran	flurandrenolide	Almirall, LLC	NDA	Current
16110-026	Cordran	flurandrenolide	Aqua Pharmaceuticals	NDA	Current
16110-026	Cordran	flurandrenolide	Almirall, LLC	NDA	Current
16110-034	Cordran	flurandrenolide	Almirall, LLC	NDA	Current
16110-034	Cordran	flurandrenolide	Aqua Pharmaceuticals	NDA	Current
16110-034	Cordran	flurandrenolide	Almirall, LLC	NDA	Current
16110-035	Cordran	flurandrenolide	Almirall, LLC	NDA	Current
16110-035	Cordran	flurandrenolide	Aqua Pharmaceuticals	NDA	Current
16110-035	Cordran	flurandrenolide	Almirall, LLC	NDA	Current
51672-5301	Flurandrenolide	Flurandrenolide	Taro Pharmaceuticals U.S.A., Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10824	SUPPL	2013-07-30
343	SUPPL	2013-06-14
12037	SUPPL	2002-07-17