Application 019821

Type: NDA
Sponsor: STIEFEL LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SORIATANE	ACITRETIN	CAPSULE;ORAL	10MG	Yes	No
002	SORIATANE	ACITRETIN	CAPSULE;ORAL	25MG	Yes	Yes
003	SORIATANE	ACITRETIN	CAPSULE;ORAL	17.5MG	Yes	No
004	SORIATANE	ACITRETIN	CAPSULE;ORAL	22.5MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
N019821-001	SORIATANE	ACITRETIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28
N019821-002	SORIATANE	ACITRETIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28
N019821-003	SORIATANE	ACITRETIN	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06
N019821-004	SORIATANE	ACITRETIN	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019821-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019821-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019821-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019821-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019821-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019821-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019821-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019821-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019821-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019821-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019821-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019821-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019821-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019821-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019821-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019821-002	AB	1	`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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acitretin	ACITRETIN	Alembic Pharmaceuticals Inc.	0a4ca401-6ea4-4653-8674-056fa637f4a1	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACITRETIN
Acitretin	ACITRETIN	Alembic Pharmaceuticals Limited	77011f2b-a2e7-4a43-9ff3-29d73f322319	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACITRETIN
ACITRETIN	ACITRETIN	Bryant Ranch Prepack	1e87e415-070d-41f5-9d93-17793e8ad8a6	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACITRETIN
ACITRETIN	ACITRETIN	Bryant Ranch Prepack	08ce9fdd-1e84-4043-b085-91053f975b64	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACITRETIN
ACITRETIN	ACITRETIN	Bryant Ranch Prepack	a5be620f-d721-40c1-a062-d21c70bfcbed	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACITRETIN
Acitretin	ACITRETIN	Amneal Pharmaceuticals of New York LLC	85507f6c-f802-479e-bacc-624b5136d092	2024-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACITRETIN
ACITRETIN	ACITRETIN	AvKARE	6af396c2-af3e-436d-ba9a-583637495910	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACITRETIN
Acitretin	ACITRETIN	Mylan Pharmaceuticals Inc.	2150bb0f-551b-4059-a97b-187d3ab22519	2023-12-20	Warnings, Adverse reactions	Name fallback generic name: ACITRETIN
ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	a6546625-acb8-460e-b34e-f795bfb3680a	2023-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACITRETIN
Acitretin	ACITRETIN	Teva Pharmaceuticals USA, Inc.	993a5325-cd10-4450-b5ea-1c0a90510df6	2022-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACITRETIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0145-0090	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
0145-0090	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
0145-0090	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
0145-0090	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
0145-0090	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
0145-0091	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
0145-0091	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
0145-0091	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
0145-0091	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
0145-0091	SORIATANE	acitretin	Stiefel Laboratories Inc	NDA	Current
66993-894	ACITRETIN	acitretin	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-894	ACITRETIN	acitretin	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-894	ACITRETIN	acitretin	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-896	ACITRETIN	acitretin	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-896	ACITRETIN	acitretin	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-896	ACITRETIN	acitretin	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73600	SUPPL	2023-02-23
73599	SUPPL	2023-02-23
73596	SUPPL	2023-02-23
49886	SUPPL	2017-09-29
49873	SUPPL	2017-09-28
1652	SUPPL	2015-05-22
11744	SUPPL	2015-05-21
19264	SUPPL	2014-05-19
11743	SUPPL	2014-05-15
1651	SUPPL	2014-02-20
11742	SUPPL	2014-02-19
19263	SUPPL	2014-02-04
33989	SUPPL	2014-01-31
43628	SUPPL	2011-11-29
33988	SUPPL	2011-11-29
1650	SUPPL	2011-11-28
19262	SUPPL	2010-02-16
33987	SUPPL	2007-10-22
19261	SUPPL	2007-10-22
11741	SUPPL	2007-10-22
1649	SUPPL	2007-10-22
41044	SUPPL	2007-07-06
20378	SUPPL	2007-07-06
1648	SUPPL	2004-11-08
33986	SUPPL	2004-10-15
1647	SUPPL	2004-10-15
33985	SUPPL	2004-04-05
19260	SUPPL	2004-03-24
19259	SUPPL	2003-05-29
1646	SUPPL	2003-05-29
33984	SUPPL	2003-04-28
11740	SUPPL	2003-04-28
20377	SUPPL	1997-06-05