Application 075027

Type: ANDA
Sponsor: PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	GEL;TOPICAL	0.05%	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
A075027-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB		1997-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075027-001	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	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`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	A075027-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075027-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075027-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075027-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075027-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075027-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075027-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075027-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075027-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075027-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075027-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075027-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075027-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075027-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075027-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075027-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075027-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075027-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075027-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075027-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075027-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075027-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075027-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075027-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075027-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075027-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075027-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075027-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075027-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075027-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075027-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075027-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075027-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075027-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075027-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075027-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075027-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075027-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075027-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075027-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	f0ca99cd-6c54-44f8-a9b3-432e93fc5d59	2025-10-08	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	1bdc1978-00d1-43f4-a127-a9d9c709644d	2024-10-30	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027 ndc (product): 63629-8639
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	bc021c6c-43db-469c-b1c3-0166b18daea4	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027 ndc (product): 63629-8637
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	695b2b8a-9d8c-4e94-bc78-2f535b8e2cbc	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027 ndc (product): 63629-8638
Clobetasol Propionate	CLOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	f9df643a-015d-4101-ac8f-c1e05b052df5	2023-03-01	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027 ndc (product): 45802-925

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-925	Clobetasol Propionate	Clobetasol propionate	Perrigo New York Inc	ANDA	Current
45802-925	Clobetasol Propionate	Clobetasol propionate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-925	Clobetasol Propionate	Clobetasol propionate	Perrigo New York Inc	ANDA	Current
45802-925	Clobetasol Propionate	Clobetasol propionate	Perrigo New York Inc	ANDA	Current
61919-329	CLOBETASOL PROPIONATE	clobetasol propionate gel	Direct RX	ANDA	Current
63629-8637	Clobetasol Propionate	Clobetasol propionate	Bryant Ranch Prepack	ANDA	Current
63629-8637	Clobetasol Propionate	Clobetasol propionate	Bryant Ranch Prepack	ANDA	Current
63629-8637	Clobetasol Propionate	Clobetasol propionate	Bryant Ranch Prepack	ANDA	Current
63629-8638	Clobetasol Propionate	Clobetasol propionate	Bryant Ranch Prepack	ANDA	Current
63629-8638	Clobetasol Propionate	Clobetasol propionate	Bryant Ranch Prepack	ANDA	Current
63629-8638	Clobetasol Propionate	Clobetasol propionate	Bryant Ranch Prepack	ANDA	Current
63629-8639	Clobetasol Propionate	Clobetasol propionate	Bryant Ranch Prepack	ANDA	Current
63629-8639	Clobetasol Propionate	Clobetasol propionate	Bryant Ranch Prepack	ANDA	Current
63629-8639	Clobetasol Propionate	Clobetasol propionate	Bryant Ranch Prepack	ANDA	Current