Application 075276

Type: ANDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	GEL, AUGMENTED;TOPICAL	EQ 0.05% BASE	No	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
A075276-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075276-001	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 · 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	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075276-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	GEL, AUGMENTED / TOPICAL	AB	RS	2003-05-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075276-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075276-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075276-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075276-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075276-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075276-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075276-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075276-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075276-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075276-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075276-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075276-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075276-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075276-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075276-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075276-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075276-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075276-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075276-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075276-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075276-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075276-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075276-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075276-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075276-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075276-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075276-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075276-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075276-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075276-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075276-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075276-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075276-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075276-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075276-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075276-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075276-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075276-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075276-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075276-001	AB	1	`f41ea6bd6efb…`

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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	79256f36-adff-4628-abc5-cb25bdfdc19d	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Cosette Pharmaceuticals, Inc.	4cc3b34f-9120-3362-0932-42d7024c8f89	2023-11-22	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	1c15cbe5-51d6-4a1a-bb42-811f1d84ae66	2023-10-31	Adverse reactions	Name fallback brand name: Betamethasone dipropionate generic name: BETAMETHASONE DIPROPIONATE
betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Viona Pharmaceuticals Inc	9adfb030-17c3-46eb-bf85-a90cabafd367	2023-08-07	Adverse reactions	Name fallback brand name: betamethasone dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	fe946b6d-2b6d-490b-8d63-c865e1c43321	2023-07-31	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	0aaa5de4-442b-4184-8378-ea47831e9663	2023-07-06	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Padagis Israel Pharmaceuticals Ltd	7bd2646c-f34a-4824-8f66-c41e77db19d2	2023-03-31	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	7da1c732-3477-4031-b776-149bd5ceea27	2023-03-06	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Actavis Pharma, Inc.	aa3f4012-7597-422d-8bcc-00102780a152	2023-02-28	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Actavis Pharma, Inc.	af8317d7-b280-4f40-ad88-802f99d33d78	2023-02-14	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Cosette Pharmaceuticals, Inc.	c9839c0a-bee5-0ef7-8933-e6231c440407	2022-11-15	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Zydus Lifesciences Limited	f531da27-2435-49a3-8992-c65240c6a7fe	2022-11-05		Name fallback brand name: betamethasone dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Zydus Pharmaceuticals USA Inc.	18d80661-72ad-4a83-917f-a80ce37a5568	2022-10-05	Adverse reactions	Name fallback brand name: Betamethasone dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Proficient Rx LP	f1be7c91-5408-4d31-8673-b691089aadce	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Padagis Israel Pharmaceuticals Ltd	e6018480-7788-472d-a2d1-ccccffcd258e	2022-02-28	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Glenmark Pharmaceuticals Inc., USA	78bdb7ca-acb0-491c-bed9-4ebbf2a07918	2020-08-31	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0266	Betamethasone Dipropionate	Betamethasone Dipropionate	E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42971	ORIG	2003-12-23
39475	ORIG	2003-12-23
8594	ORIG	2003-12-23