Application 021142

Type: NDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLUX	CLOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	0.05%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021142-001	OLUX	CLOBETASOL PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26

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 · 42 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
2026-08-18 06:07:40	2026-07	N021142-001	OLUX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021142-001	OLUX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021142-001	OLUX	0.05%	AEROSOL, FOAM / TOPICAL	AB1	RLD, RS	2000-05-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021142-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021142-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021142-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021142-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021142-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021142-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021142-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021142-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021142-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021142-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021142-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021142-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021142-001	AB1	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021142-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021142-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021142-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021142-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021142-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021142-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021142-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021142-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021142-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021142-001	AB1	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	Encube Ethicals, Inc.	8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf65	2026-04-21	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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8167	clobetasol propionate	clobetasol propionate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8182	OLUX	clobetasol propionate	Mylan Pharmaceuticals Inc.	NDA	Current
0378-8182	OLUX	clobetasol propionate	Mylan Pharmaceuticals Inc.	NDA	Current
0378-8182	OLUX	clobetasol propionate	Mylan Pharmaceuticals Inc	NDA	Current
40076-031	OLUX	clobetasol propionate	Prestium Pharma, Inc.	NDA	Current
40076-031	OLUX	clobetasol propionate	Prestium Pharma, Inc.	NDA	Current
40085-888	Clobetasol Propionate	clobetasol propionate	Renaissance Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53871	SUPPL	2018-04-27
53818	SUPPL	2018-04-26
14486	SUPPL	2014-04-25
4450	SUPPL	2014-04-24
26892	SUPPL	2006-07-21
21472	ORIG	2004-03-28
26891	SUPPL	2004-01-02
14485	SUPPL	2004-01-02
14484	SUPPL	2003-12-02
26890	SUPPL	2003-11-25
4449	SUPPL	2003-07-28
14483	SUPPL	2003-04-07
4448	SUPPL	2002-12-20
26889	SUPPL	2002-03-29
36205	ORIG	2000-05-26
4447	ORIG	2000-05-26