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 2 of 19 · 365 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Drs. Hydrocortisone Aloe Vera	HYDROCORTISONE	OL PHARMA TECH,LLC	0df06415-5d32-7ef8-e063-6294a90a6e5a	2026-07-09	Warnings	Name fallback generic name: HYDROCORTISONE
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc.	560a4abf-31dd-333f-e063-6294a90a3505	2026-07-08	Warnings	Name fallback generic name: HYDROCORTISONE
Ala-Scalp	HYDROCORTISONE	Derm Ventures LLC	61498a40-3b3c-4066-89c8-d99686e2d638	2026-07-08	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
CVS No Mess Cortisone	HYDROCORTISONE	Natural Essentials, Inc.	558c94ec-95f1-eb98-e063-6394a90a1e72	2026-07-01	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Encube Ethicals, Inc.	11e120e2-a1ca-477c-b474-bcbb72656705	2026-06-26	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Medi-First Hydrocortisone 1 % Anti-Itch Cream	HYDROCORTISONE	Unifirst First Aid Corporation	49f04e5d-746d-cbe9-e063-6294a90a7e88	2026-06-16	Warnings	Name fallback generic name: HYDROCORTISONE
Hydroxym	HYDROCORTISONE	PureTek Corporation	febffc84-e65e-e811-e053-6294a90a0ad1	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone 1% Anti-ItchCream	HYDROCORTISONE	Acme United Corporation	5425fc2b-4f25-3e64-e063-6394a90aff49	2026-06-13	Warnings	Name fallback generic name: HYDROCORTISONE
good sense anti itch	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	e51047da-8e17-4dd7-be3c-54820a7485f2	2026-06-09	Warnings	Name fallback generic name: HYDROCORTISONE
Walgreens Scalp Itch Relief	HYDROCORTISONE	Walgreens	34952272-1f9e-c642-e063-6394a90ae2bd	2026-05-29	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Mylan Pharmaceuticals Inc.	bc751403-94f2-4f9d-b533-cf6186a40ceb	2026-05-25	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
topcare hydrocortisone	HYDROCORTISONE	Topco Associates LLC	858053a0-d888-4bb9-b94e-503bcf3864cb	2026-05-21	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	04758c46-0ca4-4852-acdc-1f8553ce2e6e	2026-05-21	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Scalpicin Anti-Itch Maximum Strength	HYDROCORTISONE	Reckitt Benckiser LLC	7b1a29fa-b266-43e6-a87b-aa3c96ab4041	2026-05-13	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	02ab1006-c7c8-42c9-bda8-62c9d7142521	2026-05-11	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	058bb2ff-ff51-4a3b-ba47-cb02272d0631	2026-05-11	Adverse reactions	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	12cd35e3-e707-4551-b778-bf615c1a8d32	2026-05-11	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	0bbb8a63-ae1d-41d7-b201-d1b171b31f46	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	026728d4-846b-4bd4-9183-ae6c4a714138	2026-05-11	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Harris Teeter Hydrocortisone	HYDROCORTISONE	HARRIS TEETER LLC	4e8199f8-96ec-5342-e063-6294a90afb2d	2026-05-07	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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