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 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
N021142-001	OLUX	CLOBETASOL PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26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 · 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2026-09-14 22:38:34	2026-08	N021142-001	OLUX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021142-001	OLUX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021142-001	OLUX	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	2000-05-26	`011fe1cb6892…`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…`

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 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 · 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