Application 018662

Type: NDA
Sponsor: HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ACCUTANE	ISOTRETINOIN	CAPSULE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ACCUTANE	ISOTRETINOIN	CAPSULE;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	ACCUTANE	ISOTRETINOIN	CAPSULE;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018662-002	ACCUTANE	ISOTRETINOIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07
N018662-003	ACCUTANE	ISOTRETINOIN	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07
N018662-004	ACCUTANE	ISOTRETINOIN	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28

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 4 · 129 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	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018662-003	ACCUTANE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018662-004	ACCUTANE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1983-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018662-002	ACCUTANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-05-07	`301d65b070ca…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISOTRETINOIN	ISOTRETINOIN	Aurobindo Pharma Limited	4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6	2026-09-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Amneal Pharmaceuticals LLC	c2917c3d-3499-48a0-ba53-120cb979195d	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Zydus Pharmaceuticals USA Inc.	31f62a49-4c6d-4ce3-a0ca-d159562370b1	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Actavis Pharma, Inc.	1cf11710-f966-4529-8e08-02175f588bca	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Absorica LD	ISOTRETINOIN	Sun Pharmaceutical Industries, Inc.	3ef0cff8-19c1-4441-b780-fca6c7ee1615	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Amnesteem	ISOTRETINOIN	Mylan Pharmaceuticals Inc.	b2cb63c9-f825-4991-9a2c-6260f1bbcc2c	2026-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Claravis	ISOTRETINOIN	Teva Pharmaceuticals USA, Inc.	a31fd109-d0fd-4ab9-ba98-a3d64333c18d	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Zydus Pharmaceuticals USA Inc.	28948c32-a598-4bb5-bdb5-efbd87214d98	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
ZENATANE	ISOTRETINOIN	BluePoint Laboratories	486d4a4b-0de5-431a-bef7-dae6b0e4fa20	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Upsher-Smith Laboratories, LLC	08529687-26b2-41e5-b6fb-35b4c0d891fe	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Upsher-Smith Laboratories, LLC	c369e1c3-90c5-4768-9741-56c62253a2c4	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	5b524a51-a16b-496e-b764-11c98c479c36	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ACCUTANE generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Zydus Lifesciences Limited	245898e5-3a61-4d6a-8375-8b3a8b7364ac	2025-06-04		Name fallback generic name: ISOTRETINOIN
ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	27b3cf26-f22e-5b70-1c24-009933b7c6ee	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Zydus Lifesciences Limited	dae33df0-386c-4db5-9759-7096e770ed17	2024-11-30		Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Mayne Pharma	0114567b-3bac-490d-b9eb-03a6c5d90935	2024-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Sun Pharmaceutical Industries, Inc.	b44200ba-6672-4ea7-b151-7caec3f53c9c	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Amneal Pharmaceuticals NY LLC	9f1c8971-c6dc-4708-848b-5cee50b6c32a	2023-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Mayne Pharma	72867c88-070f-4608-bfef-cc5225ebce6d	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN
Isotretinoin	ISOTRETINOIN	Mayne Pharma	ebe1b3e3-1013-4cf6-bdc8-2baa3dc26e16	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISOTRETINOIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44440	ORIG	2015-07-02
1016	SUPPL	2010-10-26
23122	SUPPL	2010-10-25
1015	SUPPL	2010-02-05
33551	SUPPL	2010-02-04
33550	SUPPL	2009-06-10
15084	SUPPL	2008-11-21
33549	SUPPL	2007-10-10
1014	SUPPL	2007-10-10
40823	SUPPL	2007-07-06
40822	SUPPL	2007-07-06
40821	SUPPL	2007-07-06
40820	SUPPL	2007-07-06
40819	SUPPL	2007-07-06
40818	SUPPL	2007-07-06
40817	SUPPL	2007-07-06
20146	SUPPL	2007-07-06
20145	SUPPL	2007-07-06
15083	SUPPL	2005-08-15
11271	SUPPL	2005-08-12
44025	ORIG	2005-07-28
15082	SUPPL	2004-08-25
11270	SUPPL	2004-08-25
1013	SUPPL	2004-05-25
33548	SUPPL	2003-08-29
11269	SUPPL	2003-08-29
1011	SUPPL	2003-08-27
11268	SUPPL	2002-06-20
1012	SUPPL	2002-06-20
33544	SUPPL	2002-05-02
1009	SUPPL	2002-05-02
43560	SUPPL	2002-04-12
15081	SUPPL	2002-04-12
33547	SUPPL	2002-02-15
15080	SUPPL	2002-02-15
33546	SUPPL	2001-12-31
15079	SUPPL	2001-12-31
11267	SUPPL	2001-12-31
1008	SUPPL	2001-12-31
33545	SUPPL	2001-10-30
1010	SUPPL	2001-10-30
15078	SUPPL	2000-05-01
1007	SUPPL	2000-05-01
1006	SUPPL	2000-05-01