Application 021835

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBEX	CLOBETASOL PROPIONATE	SPRAY;TOPICAL	0.05%	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
N021835-001	CLOBEX	CLOBETASOL PROPIONATE	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021835-001	AT

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021835-001	CLOBEX	0.05%	SPRAY / TOPICAL	AT	RLD, RS	2005-10-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021835-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021835-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021835-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021835-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021835-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021835-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021835-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021835-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021835-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021835-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021835-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021835-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021835-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021835-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021835-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021835-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021835-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021835-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021835-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021835-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021835-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021835-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021835-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021835-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021835-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021835-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021835-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021835-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021835-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021835-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021835-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021835-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021835-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021835-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021835-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021835-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021835-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021835-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021835-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021835-001	AT	1	`f41ea6bd6efb…`

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 2 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	NuCare Pharmaceuticals, Inc.	4524d04c-de48-6671-e063-6294a90a0e33	2025-12-04	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	49bfff2e-9e4d-48a4-9f74-d6cf5b312aca	2025-11-30	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	4990e4c7-78b3-4bc8-85d0-6d58f08121ff	2025-11-04	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	40c3b94f-a61c-4fc1-a411-5bf4e3fe6791	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Lupin Pharmaceuticals, Inc.	0a267001-0bff-471c-8852-808e6e3ea37c	2025-10-14	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Lupin Pharmaceuticals, Inc.	93f3763f-9f2f-4e81-bf6c-db35af45cd64	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	f0ca99cd-6c54-44f8-a9b3-432e93fc5d59	2025-10-08	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	The J. Molner Company LLC	26ccb1d8-c466-e238-e063-6394a90a0069	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	9856b731-0676-405d-817c-de385cbd08a3	2025-09-30	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	643682ee-39c8-4a0d-b131-f30077e6e20a	2025-09-03	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	21a63bc2-a42a-412c-8dd5-17e279f99f27	2025-09-03	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	6d14d269-bae6-493a-81ed-83f6a3aa0f4f	2025-09-03	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	91571297-03ad-441e-8ec6-f78c21fbe5e8	2025-08-22	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Xiromed, LLC	2556987f-4b0f-8a83-5bf4-095d67a450b4	2025-08-12	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	NORTHSTAR RX LLC	72c90da7-5f6a-4b8d-875d-f07ceeec295e	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	2d4fa3a3-dc1c-4d3c-9959-4751e09d25be	2025-07-08	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	04d7d65b-d7ed-4223-abab-5d0aed36a155	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	d4c73fb0-9675-4c41-a8bd-dd4cb2db1169	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	f5ea346b-f507-4224-88a6-4c891c4b1ad5	2025-07-03	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	d8246614-757b-4e27-8c3e-37fcb401e6d9	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-3849	CLOBEX	clobetasol propionate	Galderma Laboratories, L.P.	NDA	Current
0591-4039	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57086	SUPPL	2018-12-31
57016	SUPPL	2018-12-26
16433	SUPPL	2012-09-11
28677	SUPPL	2012-09-10
28678	SUPPL	2012-08-20
16434	SUPPL	2012-08-20
37736	SUPPL	2011-01-14
37735	SUPPL	2011-01-14
28676	SUPPL	2011-01-14
6277	SUPPL	2011-01-14
21838	ORIG	2007-07-03
28675	ORIG	2005-11-01
16432	ORIG	2005-11-01