Application 018865

Type: NDA
Sponsor: FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	OINTMENT;TOPICAL	EQ 0.1% BASE	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
N018865-001	BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018865-001	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 · 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	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018865-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AB	RLD, RS	1983-08-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018865-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018865-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018865-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018865-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018865-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018865-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018865-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018865-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018865-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018865-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018865-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018865-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018865-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018865-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018865-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018865-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018865-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018865-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018865-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018865-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018865-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018865-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018865-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018865-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018865-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018865-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018865-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018865-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018865-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018865-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018865-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018865-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018865-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018865-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018865-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018865-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018865-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018865-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018865-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018865-001	AB	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Valerate	BETAMETHASONE VALERATE	Preferred Pharmaceuticals Inc.	50d4763d-5a84-4c45-be06-040c4a527470	2026-03-19	Adverse reactions	Exact identifier application applno (NDA): 018865 application number: NDA018865
Betamethasone Valerate	BETAMETHASONE VALERATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0b386ccc-a2d4-4d18-a2d7-e46ff894c674	2026-01-28	Adverse reactions	Exact identifier application applno (NDA): 018865 application number: NDA018865 ndc (product): 0168-0033

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0033	Betamethasone Valerate	betamethasone valerate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	NDA	Current
0168-0033	Betamethasone Valerate	betamethasone valerate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	NDA	Current
0168-0033	Betamethasone Valerate	betamethasone valerate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	NDA	Current
21695-586	Betamethasone Valerate	betamethasone valerate	Rebel Distributors Corp	ANDA	Current
50090-0165	Betamethasone Valerate	betamethasone valerate	A-S Medication Solutions	NDA	Current
68788-7095	Betamethasone Valerate	betamethasone valerate	Preferred Pharmaceuticals Inc.	NDA	Current
68788-7095	Betamethasone Valerate	betamethasone valerate	Preferred Pharmaceuticals Inc.	NDA	Current
68788-7095	Betamethasone Valerate	betamethasone valerate	Preferred Pharmaceuticals Inc.	NDA	Current