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 1.

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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021535-001	CLOBEX	0.05%	LOTION / TOPICAL	AB	RLD, RS	2003-07-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N021535-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021535-001	AB	1	`cb3db0bc1861…`

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 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	a83d212b-a970-4ee7-8431-fead6b2e7f9d	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	AvKARE	a86241e0-3187-e468-e053-2995a90a1ae5	2026-07-15	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	d8f560c8-e223-46f0-8afb-b418f2b6399c	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	91e7bf57-d236-4b9b-8241-e71e5e93617a	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	446209ba-61ad-46b5-99f7-039ae7fca757	2026-07-06	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	8da21ad7-4d2d-4168-82ee-ebf13ce5e923	2026-06-23	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Amneal Pharmaceuticals NY LLC	4363539b-d25e-4da3-911c-9ba142d7f4f4	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Torrent Pharmaceuticals Limited	6f930298-e410-4bfb-8c3f-456a1f55f4a9	2026-05-08	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Golden State Medical Supply, Inc.	04180cdf-c63a-d524-e063-6394a90a2d06	2026-04-23	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	cb0bc057-d6ab-4eea-af7a-01661ae9b517	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	A-S Medication Solutions	c26e6e8f-9670-48c5-917b-e73e5589579a	2026-04-14	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	4a761afb-a48a-4a5a-8700-ad93601a260f	2026-03-23	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Micro Labs Limited	85aea21d-c4ff-4558-b416-516fa93bea1f	2026-03-16	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	NorthStar RxLLC	3d14fff7-f1af-4d15-96b4-88cfccad271f	2026-02-11	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	6a3ad15e-2874-40d0-9e69-105b369c8cfc	2026-01-31	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	db8c7a36-e950-44b9-b2ff-7fede2e87407	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Glenmark Pharmaceutcials Inc., USA	69794e0b-2a79-419e-844f-ed051be62249	2026-01-28	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	736325f3-a369-4d70-b608-3d6ba37b6a6b	2026-01-28	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
BYQLOVI	CLOBETASOL PROPIONATE	Harrow Eye, LLC	31ca5a0f-812e-491d-aa00-d8ed424ba322	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	NuCare Pharmaceuticals, Inc.	4524d04c-de48-6671-e063-6294a90a0e33	2025-12-04	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE

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