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 2 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	52c0e92f-986e-45e7-99cf-9a13ac386b1d	2025-07-28	Adverse reactions	Name fallback brand name: BETAMETHASONE DIPROPIONATE generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Golden State Medical Supply, Inc.	9571a031-179d-7dfb-e053-2995a90aa016	2025-07-10	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	3b23a3c0-3306-4a2d-932d-25916d16dc68	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	dc3dd2f7-38ad-4c4c-8602-29b33cc6af90	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Betamethasone dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	bc12c828-54ba-411d-b752-9b735f7adf63	2025-07-02	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	e041ceb2-8bda-4703-b663-804e7b462e32	2025-07-02	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	NuCare Pharmaceuticals,Inc.	75862805-2cfc-fb45-e053-2991aa0a1403	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	07a35811-7298-4f25-b280-e2f9aeab9830	2025-04-01	Adverse reactions	Name fallback brand name: Betamethasone dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	018fcec3-bfb4-451c-9b54-d1fd389c2a44	2025-03-14	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Northstar Rx LLC.	395d40c0-22d9-48d1-8d8e-eeaddf33c53e	2024-12-05	Adverse reactions	Name fallback brand name: Betamethasone dipropionate generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Burel Pharmaceuticals, LLC	c8bda9a8-4dec-4084-84e5-4b4623390bd8	2024-12-04	Warnings, Adverse reactions	Name fallback brand name: BETAMETHASONE DIPROPIONATE generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Zydus Lifesciences Limited	bc9ca1f4-8f40-44e1-bb2d-42ecba35d406	2024-11-25		Name fallback brand name: Betamethasone dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Asclemed USA, Inc	86994546-929c-4303-89e4-31ba271673cf	2024-10-11	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	d6702ddc-4a1d-4d0d-bebd-bc615ed0bc35	2024-08-30	Adverse reactions	Name fallback brand name: BETAMETHASONE DIPROPIONATE generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	0481ac0d-9220-472b-b3f2-af6e0bb6962d	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	5137f94e-6818-440b-a33e-228aa27de61d	2024-07-30	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	NuCare Pharmaceuticals,Inc.	84b37e6a-779e-5d43-e053-2a91aa0a16b7	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Aurobindo Pharma Limited	e0e0baea-1744-4708-bda7-4ab7783a3fb4	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: BETAMETHASONE DIPROPIONATE generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Actavis Pharma, Inc.	ab332791-461b-4396-9b46-7f00bc04c087	2024-04-08	Adverse reactions	Name fallback brand name: Betamethasone Dipropionate generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Padagis Israel Pharmaceuticals Ltd	0e56e8bc-b79e-43c6-945e-c333a599bfc8	2024-03-31	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