Application 088215

Type: ANDA
Sponsor: ALLERGAN HERBERT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENECORT	HYDROCORTISONE	GEL;TOPICAL	1%	No	No

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
A088215-001	PENECORT	HYDROCORTISONE	1%	GEL / TOPICAL			1984-06-06

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088215-001	PENECORT	1%	GEL / TOPICAL	1984-06-06	`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 12 of 19 · 377 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Walgreens Co.	c22bba5c-bb6f-494e-987a-f6e36c1b4893	2025-03-06	Warnings	Name fallback generic name: HYDROCORTISONE
Thera Plus Hydrocortisone Maximum Strength	HYDROCORTISONE	FOURSTAR GROUP USA, INC.	c2bc8f0c-38ea-4124-bc51-bf22e6751a92	2025-03-04	Warnings	Name fallback generic name: HYDROCORTISONE
Thera Plus Eczema Hydrocortisone Anti Itch	HYDROCORTISONE	Fourstar Group USA, Inc.	7c72217b-db9a-4573-9f14-4c11528fa452	2025-03-04	Warnings	Name fallback generic name: HYDROCORTISONE
Thera Plus Maximum Strength Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	fb89dca6-c0c0-4092-b3f5-e59c956c3d6c	2025-03-04	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone with aloe	HYDROCORTISONE	Encube Ethicals, Inc.	12a1774d-a97e-4787-b6b1-8e8cd40b7b70	2025-02-26	Warnings	Name fallback generic name: HYDROCORTISONE
Family Wellness Max Strength 1 Hydrocortisone Cream	HYDROCORTISONE	Family Dollar Stores, Inc	bca5ac2c-45cd-44e3-98f1-317a04e44d7d	2025-02-25	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Ultra Soothing Itch Relief	HYDROCORTISONE	Chattem, Inc.	8a9e2d32-a65f-4253-8041-4146f4e3b738	2025-02-21	Warnings	Name fallback generic name: HYDROCORTISONE
CORTEF	HYDROCORTISONE	Pharmacia & Upjohn Company LLC	9ce19944-dd88-4a7b-84ca-b07f4ec23bad	2025-02-17	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
signature care Hydrocortisone	HYDROCORTISONE	Safeway	9fe16fc5-77e3-47f5-a943-85bc6565c0d4	2025-02-06	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc	ded2eb00-88ce-42b7-858e-4645c6f13239	2025-02-05	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Intensive Healing Itch Relief Cream	HYDROCORTISONE	Chattem, Inc.	cdbeb825-3152-4f74-9fd1-93bccfc0e31a	2025-02-01	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Soothing Aloe Itch Relief	HYDROCORTISONE	Chattem, Inc.	1962abb3-6ca7-4934-9efe-20287b1c2a5b	2025-02-01	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0cb39a3d-4d3b-4820-b3bd-eff642e08a41	2025-01-28	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Gerigentle	HYDROCORTISONE	GERI-GENTLE CORPORATION	0adfa2f0-9758-5c54-e063-6294a90a461f	2025-01-25	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	DIRECT RX	c28c3ceb-1807-b43b-e053-2995a90a2aba	2025-01-17	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Equate Hydrocortisone Topical	HYDROCORTISONE	WalMart	1f64555d-f77e-4a83-b222-fdb3ed7d8853	2025-01-16	Warnings	Name fallback generic name: HYDROCORTISONE
Equate Hydrocortisone	HYDROCORTISONE	WalMart	f5c32b4a-1159-4b7a-b8ac-256d53020dc2	2025-01-16	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	AvPAK	f3956208-291c-7374-e053-2a95a90a4628	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
ANTI ITCH	HYDROCORTISONE	Safeway	0bfa1653-76b7-48ed-a896-a0b5fc3bd794	2025-01-08	Warnings	Name fallback generic name: HYDROCORTISONE
AVON HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	8f2aa11d-d794-6f3e-e053-2995a90a1d9d	2025-01-01	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.