Application 076592

Type: ANDA
Sponsor: PERRIGO ISRAEL

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	No

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
A076592-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076592-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`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	A076592-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076592-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076592-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076592-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076592-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076592-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076592-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076592-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076592-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076592-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076592-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076592-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076592-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076592-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076592-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076592-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076592-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076592-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076592-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076592-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076592-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076592-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076592-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076592-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076592-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076592-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076592-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076592-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076592-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076592-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076592-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076592-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076592-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076592-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076592-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076592-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076592-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076592-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076592-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076592-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Preferred Pharmaceuticals, Inc.	5683885d-461c-4e7e-bbe8-dc231d706192	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592 ndc (product): 68788-9219
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	f2c557ea-275b-4ab4-90f4-4003e022214d	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	0481ac0d-9220-472b-b3f2-af6e0bb6962d	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592 ndc (product): 63629-8613
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	NuCare Pharmaceuticals,Inc.	84b37e6a-779e-5d43-e053-2a91aa0a16b7	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592 ndc (product): 68071-4814
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	79256f36-adff-4628-abc5-cb25bdfdc19d	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592 ndc (product): 63629-8614
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Padagis Israel Pharmaceuticals Ltd	7bd2646c-f34a-4824-8f66-c41e77db19d2	2023-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592 ndc (product): 45802-376
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Proficient Rx LP	f1be7c91-5408-4d31-8673-b691089aadce	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592 ndc (product): 71205-275

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-376	Betamethasone Dipropionate	Betamethasone Dipropionate	Perrigo New York Inc	ANDA	Current
45802-376	Betamethasone Dipropionate	Betamethasone Dipropionate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-376	Betamethasone Dipropionate	Betamethasone Dipropionate	Perrigo New York Inc	ANDA	Current
50090-1192	Betamethasone Dipropionate	Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
53002-8280	Betamethasone Dipropionate	Betamethasone Dipropionate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-8280	Betamethasone Dipropionate	Betamethasone Dipropionate	RPK Pharmaceuticals, Inc.	ANDA	Current
63629-8613	Betamethasone Dipropionate	Betamethasone Dipropionate	Bryant Ranch Prepack	ANDA	Current
63629-8613	Betamethasone Dipropionate	Betamethasone Dipropionate	Bryant Ranch Prepack	ANDA	Current
63629-8613	Betamethasone Dipropionate	Betamethasone Dipropionate	Bryant Ranch Prepack	ANDA	Current
63629-8614	Betamethasone Dipropionate	Betamethasone Dipropionate	Bryant Ranch Prepack	ANDA	Current
63629-8614	Betamethasone Dipropionate	Betamethasone Dipropionate	Bryant Ranch Prepack	ANDA	Current
63629-8614	Betamethasone Dipropionate	Betamethasone Dipropionate	Bryant Ranch Prepack	ANDA	Current
68071-2850	Betamethasone Dipropionate	Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4814	Betamethasone Dipropionate	Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4814	Betamethasone Dipropionate	Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9219	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9219	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9219	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9219	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9219	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-275	Betamethasone Dipropionate	Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
71205-275	Betamethasone Dipropionate	Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
71205-275	Betamethasone Dipropionate	Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
71205-275	Betamethasone Dipropionate	Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current