Application 021535

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	LOTION;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
N021535-001	CLOBEX	CLOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021535-001	AB

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	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`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	N021535-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021535-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021535-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021535-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021535-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021535-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021535-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021535-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021535-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021535-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021535-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021535-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021535-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021535-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021535-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021535-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021535-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021535-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021535-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021535-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021535-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021535-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021535-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021535-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021535-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021535-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021535-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021535-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021535-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021535-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021535-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021535-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021535-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021535-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021535-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021535-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021535-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021535-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021535-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021535-001	AB	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 5 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	Macleods Pharmaceuticals Limited	5ad9c808-6095-4d86-b140-e0f6d4079a3a	2022-12-23	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Zydus Pharmaceuticals USA Inc.	8618a3bc-5601-4273-a708-27b0ecd4c385	2022-10-06	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Zydus Pharmaceuticals USA Inc.	98a25409-e84e-452b-8dc5-ad87842398e1	2022-10-05	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate emollient formulation	CLOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	5264dfb8-3f6f-4f20-958d-9b5855806dc8	2022-03-31	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	3f75880b-9ead-4c6e-b999-3bd7e1643ce5	2022-03-31	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	fdfd83ee-dfb4-4c12-a74e-a0053e34e08c	2021-07-01	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Northstar Rx LLC	0d0e8e82-2b57-4cc0-a46b-bd08fb581deb	2021-05-31	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Xiromed, LLC	56e6d233-d9ee-f022-3be7-d100799a561e	2020-11-06	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	dfc58f73-e892-4fc3-8726-4e8d1546ebd3	2020-09-07	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	420deed6-321f-4a2a-9042-1e61636621aa	2020-08-26	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Actavis Pharma, Inc.	afd20e23-b7a6-46ca-bd8d-b7af9ff84201	2020-02-29	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Lupin Pharmaceuticals,Inc.	3e0fe7b1-f511-491f-b74d-3ca00449835b	2018-08-10	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	e37dd885-889a-4bfd-9813-bb7b9b96cee1	2018-04-18	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Novel Laboratories, Inc.	c7c03887-f84a-417e-a8f1-5272f530d0bb	2016-05-21	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Novel Laboratories, Inc.	afa1c879-36b9-401e-85d4-638ceec8f444	2016-04-28	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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-3848	Clobex	Clobetasol Propionate	Galderma Laboratories, L.P.	NDA	Current
0574-2103	Clobetasol Propionate	Clobetasol Propionate	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0574-2103	Clobetasol Propionate	Clobetasol Propionate	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0574-2103	Clobetasol Propionate	Clobetasol Propionate	Paddock Laboratories, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
15712	SUPPL	2014-01-14
5668	SUPPL	2012-12-03
28048	SUPPL	2012-08-20
15711	SUPPL	2012-08-20
21721	ORIG	2004-06-14
28047	ORIG	2003-07-28
15710	ORIG	2003-07-28