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 14 of 19 · 377 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DG health hydrocortisone	HYDROCORTISONE	Dolgencorp, LLC	40710bae-32bb-47fd-b3dd-31d2c98ee70f	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
careone anti itch	HYDROCORTISONE	American Sales Company	5f7b1435-ebee-4093-847a-79e8d6641404	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	ALLIED TRADE LINK LLC	26bc238d-3bda-0c29-e063-6394a90a35fb	2024-11-12	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Acme United Corporation	fabcaa3b-d189-bd29-e053-6294a90ae86b	2024-11-12	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Kroger Company	fc1677f2-4078-4ebd-9c3b-86a29a35b489	2024-11-12	Warnings	Name fallback generic name: HYDROCORTISONE
Aveeno Hydrocortisone ANTI-ITCH	HYDROCORTISONE	Kenvue Brands LLC	233de4d7-e533-40cd-a5ed-e8b09abc626e	2024-11-05	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone with Aloe	HYDROCORTISONE	A-S Medication Solutions	3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3	2024-11-04	Warnings	Name fallback generic name: HYDROCORTISONE
cortisone	HYDROCORTISONE	CVS Pharmacy	c766deac-d993-4e48-a5c3-4cfde7338dff	2024-10-31	Warnings	Name fallback generic name: HYDROCORTISONE
dg health hydrocortisone	HYDROCORTISONE	Dolgencorp, LLC	27dc9e09-fc4f-4b66-a303-177725f3a513	2024-10-31	Warnings	Name fallback generic name: HYDROCORTISONE
basic care hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	f5419859-3f9f-43ff-9a3f-6aa81af044f0	2024-10-31	Warnings	Name fallback generic name: HYDROCORTISONE
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	beefab66-b056-4bf1-b047-0780704ab87e	2024-10-29	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	H E B	15eb4676-5f6e-4c28-b5b9-4e45412dc37a	2024-10-29	Warnings	Name fallback generic name: HYDROCORTISONE
Monistat Complete Care Instant Itch Relief	HYDROCORTISONE	Insight Pharmaceuticals LLC	a0f40504-6183-4f32-8d17-6586b3f386a6	2024-10-25	Warnings	Name fallback generic name: HYDROCORTISONE
Dermarest Eczema Medicated	HYDROCORTISONE	Insight Pharmaceuticals LLC	0292ab62-5088-45fa-a056-70c2fcc19ef7	2024-10-25	Warnings	Name fallback generic name: HYDROCORTISONE
anti itch	HYDROCORTISONE	Meijer, Inc.	2db7bcab-acb8-48ad-8cd1-842ff7765ed9	2024-10-23	Warnings	Name fallback generic name: HYDROCORTISONE
berkley and jensen anti itch	HYDROCORTISONE	BJWC	5cc6e4f6-c62d-4923-9726-9dbc569a3f49	2024-10-19	Warnings	Name fallback generic name: HYDROCORTISONE
DG Health Hydrocortisone Maximum Strength	HYDROCORTISONE	Dolgencorp Inc	2cc792b8-dce6-4178-bd6d-63ba268b7747	2024-10-19	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	H E B	25ec9014-64c4-44df-9e67-9f9223ffc923	2024-10-12	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	24221805-e5c9-5785-e063-6394a90a9d2f	2024-10-10	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	2410dc2f-9332-19fa-e063-6394a90a2835	2024-10-09	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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