Application 020934

Type: NDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUXIQ	BETAMETHASONE VALERATE	AEROSOL, FOAM;TOPICAL	0.12%	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
N020934-001	LUXIQ	BETAMETHASONE VALERATE	0.12% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28

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	N020934-001	LUXIQ	0.12% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020934-001	LUXIQ	0.12% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020934-001	LUXIQ	0.12% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020934-001	LUXIQ	0.12% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL		RLD	1999-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020934-001	LUXIQ	0.12%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	1999-02-28	`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	N020934-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020934-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020934-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020934-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020934-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020934-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020934-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020934-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020934-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020934-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020934-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020934-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020934-001	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020934-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020934-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020934-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020934-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020934-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020934-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020934-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020934-001	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 1 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Valerate	BETAMETHASONE VALERATE	Sun Pharmaceutical Industries, Inc.	7c96b978-25ff-44c2-bc9c-30ff5e34cffb	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Preferred Pharmaceuticals Inc.	50d4763d-5a84-4c45-be06-040c4a527470	2026-03-19	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	Preferred Pharmaceuticals, Inc.	bfa4b6f5-3b66-430a-af41-60e3f12982bc	2026-03-19	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	A-S Medication Solutions	7281d272-5342-4738-b35c-42570459e9d4	2026-02-04	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0b386ccc-a2d4-4d18-a2d7-e46ff894c674	2026-01-28	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	Sun Pharmaceutical Industries, Inc.	3c85be0f-2731-44f1-a18e-d3852d54846f	2025-10-02	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone valerate	BETAMETHASONE VALERATE	Alembic Pharmaceuticals Limited	75d70e76-023c-4a00-954d-79a697bed80f	2025-09-25	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Preferred Pharmaceuticals Inc.	985d1f62-4bff-4bf1-b7c7-96cb456ef83d	2025-02-07	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	A-S Medication Solutions	02db1402-701c-483c-bfd6-8b7a543ae8ef	2024-11-11	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone valerate	BETAMETHASONE VALERATE	Alembic Pharmaceuticals Inc.	3b6fa573-de04-4626-a39a-dca39def6df2	2024-08-23	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	NuCare Pharmaceuticals,Inc.	a2154b33-0f61-49af-e053-2995a90a1810	2024-06-20	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	NuCare Pharmaceuticals,Inc.	64badc1a-8922-c6e3-e053-2991aa0a8b1c	2024-06-06	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Padagis Israel Pharmaceuticals Ltd	dc5dfd3e-7762-40c8-880e-c7db80d87749	2024-03-31	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	A-S Medication Solutions	f8711d17-de6a-45e3-8027-b650308207ed	2023-12-15	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	A-S Medication Solutions	d265d143-343f-41ec-9cb4-18d83edb772b	2023-12-12	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Proficient Rx LP	036706f1-0a24-4765-9a62-820ad64934be	2022-06-01	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Cosette Pharmaceuticals, Inc.	784476d2-5e5c-fdba-a677-8973a777b5ef	2022-05-05	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Proficient Rx LP	2a64b65b-8a49-45ea-9464-2269751c075c	2021-04-01	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8180	Betamethasone Valerate	Betamethasone Valerate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8187	Luxiq	Betamethasone Valerate	Mylan Pharmaceuticals Inc.	NDA	Current
40076-021	Luxiq	Betamethasone Valerate	Prestium Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49010	SUPPL	2017-07-18
3787	SUPPL	2006-07-13
35664	SUPPL	2004-01-02
26228	SUPPL	2004-01-02
26227	SUPPL	2003-12-04
3785	SUPPL	2002-10-09
3786	SUPPL	2002-10-08
3784	SUPPL	2002-02-28
21283	ORIG	1999-06-16
35663	ORIG	1999-02-28
26226	ORIG	1999-02-28