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 3 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	Alembic Pharmaceuticals Limited	6fc0d1ac-f357-4038-8004-263bfaed4eaf	2025-04-25	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Eyenovia, Inc.	7687c980-7006-4222-80b9-c32773772d3e	2025-04-16	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	2d0b48d9-dbfb-4265-b73b-07faf217ae6e	2025-04-02	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	fc3ac7b5-0cd5-4d31-97e4-b01c0f715835	2025-03-28	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	a4f74fc7-d2f6-4cf2-9cc5-60078bde55a7	2025-03-26	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	46bda1db-c2eb-461a-bcd0-dfdb6c7f542d	2025-03-18	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	2b7f0643-679c-4586-a3a0-31eae4a36f19	2025-03-18	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	INA Pharmaceutics Inc	1b0e9eb5-71eb-44b4-894a-094a9f325dc8	2025-02-13	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	1a4331e1-5c79-44c3-a691-4b808a3bde97	2025-02-12	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	96f20fcd-aa96-4472-807b-43094befc8a9	2025-02-10	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Macleods Pharmaceuticals Limited	44ced6ce-fa10-426d-a498-a13b8b34f49a	2025-01-29	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	DIRECT RX	cc716dab-b535-8b51-e053-2995a90a8f16	2025-01-20	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Tovet (emollient formulation)	CLOBETASOL PROPIONATE	Medimetriks Pharmaceuticals, Inc.	4d5c5b14-9e4f-4d43-a336-e4ae71d34e42	2024-12-12	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Zydus Lifesciences Limited	287ce325-4449-4342-a9ef-a7e31ee692bd	2024-11-26		Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Zydus Lifesciences Limited	30f4c173-189d-4b29-8d7d-e82e5c0743cf	2024-11-26		Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	1bdc1978-00d1-43f4-a127-a9d9c709644d	2024-10-30	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Viona Pharmaceuticals Inc	2fc7de5f-094f-400c-b87e-750b16046f46	2024-08-16	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Zydus Lifesciences Limited	d01b8f72-c2d2-49d8-87d7-3d60f11a7bbb	2024-08-14		Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb	2024-03-14	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Proficient Rx LP	e0f7bc85-9c13-44df-9b37-c216ecfe3ffe	2024-03-01	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