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 6 of 19 · 377 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortizone-10 Soothing Aloe Creme	HYDROCORTISONE	Chattem, Inc.	1a841bf0-9d7b-4566-b442-aa9bcc827846	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortisone 10 Sensitive Skin Creme	HYDROCORTISONE	Chattem, Inc.	b139917c-00bb-4cb3-995d-a6d2f2c295c6	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortisone 10 Intensive Moisture Creme	HYDROCORTISONE	Chattem, Inc.	096a9af3-7e7c-4dae-bc22-44061c60d3c9	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Easy Relief	HYDROCORTISONE	Chattem, Inc.	beb73818-cd88-44ff-8ecd-b02b910b53b7	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Feminine Itch Relief	HYDROCORTISONE	Chattem, Inc.	c0c0c1fb-43c9-4903-bb3b-f0885619b8cc	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Ultra Soothing Creme	HYDROCORTISONE	Chattem, Inc.	4b62615f-e713-42f2-8b9c-9eebf8d1b270	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Fast Acting Itch Relief Cooling	HYDROCORTISONE	Chattem, Inc.	01cd77e3-380f-4487-ae6e-3ac45355d8a4	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	0174411c-1b10-4298-b820-87b24065b118	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Intensive Healing for Eczema	HYDROCORTISONE	Chattem, Inc.	31dc0f1f-ddd8-41dc-b669-b24655634d55	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortisone 10 Overnight Creme	HYDROCORTISONE	Chattem, Inc.	ef2eda7e-d6a8-47e3-9d80-6074af6773dc	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Crown Laboratories	a84830ad-73dc-4a2e-b987-0a1103526535	2026-01-12	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Alacort	HYDROCORTISONE	Crown Laboratories	de000081-a245-4f6b-9e7c-e47d84b82338	2026-01-12	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Texacort	HYDROCORTISONE	Mission Pharmacal Company	25279d46-6bad-471f-8bd6-736d53cfd942	2026-01-08	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Strides Pharma Inc.	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone 1% Anti-Itch Cream	HYDROCORTISONE	DLC Laboratories, Inc.	16eeec2c-065d-4da0-e063-6294a90a3873	2026-01-07	Warnings	Name fallback generic name: HYDROCORTISONE
Maximum Strength Hydrocortisone	HYDROCORTISONE	DLC Laboratories, Inc	caf50f12-f35c-4e9e-8ef7-3b0c84e225ee	2026-01-07	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	7ba59aa6-b828-4048-bf86-90c90d9894a0	2026-01-06	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Procto-Med HC	HYDROCORTISONE	Leading Pharma, LLC	0682580e-aff8-4b67-99ba-a29ab7b433db	2026-01-06	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	AKRON PHARMA INC	fa956b6a-1712-4f7a-9490-11866dcd17c8	2025-12-29	Warnings	Name fallback generic name: HYDROCORTISONE
Nizoral Scalp Itch Relief	HYDROCORTISONE	Kramer Laboratories	dba59238-6beb-447e-8c4c-e4bc00fd2c20	2025-12-23	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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