Application 078930

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	CREAM, AUGMENTED;TOPICAL	EQ 0.05% BASE	No	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
A078930-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL			2008-09-23

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	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL			2008-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL			2008-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL			2008-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL			2008-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2008-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2008-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2008-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2008-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078930-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2008-09-23	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078930-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078930-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078930-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078930-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078930-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078930-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078930-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078930-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078930-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078930-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078930-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078930-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078930-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078930-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078930-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078930-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078930-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078930-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078930-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078930-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078930-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078930-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078930-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078930-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078930-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078930-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078930-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078930-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078930-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078930-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078930-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078930-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078930-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078930-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078930-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078930-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078930-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Glenmark Pharmaceuticals Inc., USA	78bdb7ca-acb0-491c-bed9-4ebbf2a07918	2020-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078930 application number: ANDA078930 ndc (product): 68462-290

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2091	Betamethasone Dipropionate	Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
50090-2091	Betamethasone Dipropionate	Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
50090-2091	Betamethasone Dipropionate	Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
52959-124	Betamethasone Dipropionate	Betamethasone Dipropionate	H.J. Harkins Company, Inc.	ANDA	Current
63187-433	Betamethasone Dipropionate	Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
68071-1635	Betamethasone Dipropionate	Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1657	Betamethasone Dipropionate	Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1657	Betamethasone Dipropionate	Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-290	Betamethasone Dipropionate	Betamethasone Dipropionate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-290	Betamethasone Dipropionate	Betamethasone Dipropionate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-290	Betamethasone Dipropionate	Betamethasone Dipropionate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-290	Betamethasone Dipropionate	Betamethasone Dipropionate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68788-7241	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals Inc., USA	ANDA	Current
68788-7241	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals Inc., USA	ANDA	Current
68788-7241	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals Inc., USA	ANDA	Current
68788-7241	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals Inc., USA	ANDA	Current
68788-7241	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals Inc., USA	ANDA	Current
68788-9804	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9804	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9804	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9804	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9804	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current