Application 089066

Type: ANDA
Sponsor: PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STIE-CORT	HYDROCORTISONE	LOTION;TOPICAL	1%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A089066-001	STIE-CORT	HYDROCORTISONE	1%	LOTION / TOPICAL			1985-11-25

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089066-001	STIE-CORT	1%	LOTION / TOPICAL	1985-11-25	`3a93d1ddd44b…`

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 · 365 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Hydrocortisone	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	b2918ac7-14b5-4372-9055-8caf6f4bcf37	2025-12-22	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Caring Mills Hydrocortisone	HYDROCORTISONE	Veridian Healthcare	b0b1889b-3099-4943-a4cb-d9a898a06860	2025-12-22	Warnings	Name fallback generic name: HYDROCORTISONE
Kroger Anti Itch	HYDROCORTISONE	The Kroger Co	46547277-f11a-b9e7-e063-6294a90a2ccd	2025-12-19	Warnings	Name fallback generic name: HYDROCORTISONE
Aquaphor Itch Relief	HYDROCORTISONE	Beiersdorf Inc	b1d0333f-ba60-35d8-e053-2995a90af932	2025-12-16	Warnings	Name fallback generic name: HYDROCORTISONE
equate hydrocortisone	HYDROCORTISONE	Wal-Mart Stores Inc	70f4636d-4137-498b-ab81-0330de883e53	2025-12-15	Warnings	Name fallback generic name: HYDROCORTISONE
TrueLipids 1% Hydrocortisone Barrier Cream	HYDROCORTISONE	Claridei Laboratories	037395dc-5b96-052e-e063-6394a90a26e4	2025-12-15	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Rectal Suspension (Retention)	HYDROCORTISONE	Chartwell RX LLC	3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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