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 18 of 19 · 364 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-itch Paraben Free	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c5419c5-0929-7ca6-e063-6294a90ac0a7	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Anti itch	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c58b750-d3a6-5ed1-e063-6294a90a4321	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Quatriderm Anti-itch	HYDROCORTISONE	OPMX LLC	83e59e10-9878-e5c2-e053-2a91aa0af25e	2023-12-04	Warnings	Name fallback generic name: HYDROCORTISONE
Bloop Itch Soothing Topical	HYDROCORTISONE	Three Nations Corp	0b64677e-d4bf-0929-e063-6294a90af137	2023-11-30	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5ee2f62a-d8d5-4efd-bf6f-f79c10855631	2023-11-22	Adverse reactions	Name fallback generic name: HYDROCORTISONE
TOTAL RELIEF	HYDROCORTISONE	DR. MARDER SKINCARE, LLC	2c05459c-5a2c-45ab-b534-87f966b41681	2023-11-11	Warnings	Name fallback generic name: HYDROCORTISONE
KERA HC	HYDROCORTISONE	Clinical Therapeutic Solutions	ac215c8f-b224-480c-9295-3a34316293ba	2023-11-10	Warnings	Name fallback generic name: HYDROCORTISONE
SKIN A COOL Hydrocortisone Anti-Itch	HYDROCORTISONE	Ana-Cool, LLC	e3ea7406-e494-4038-9b28-8d0a28b4b834	2023-11-10	Warnings	Name fallback generic name: HYDROCORTISONE
Ana Cool Rapid Soothing Cooling Formula	HYDROCORTISONE	Ana-Cool, LLC	64b80cc2-e2d8-4535-aaf8-c031f4159cd1	2023-11-05	Warnings	Name fallback generic name: HYDROCORTISONE
Dr. Sheffield Hydrocortisone Anti itch	HYDROCORTISONE	Sheffield Pharmaceuticals LLC	71c9f2f4-2188-45eb-b55e-3856ac78070b	2023-10-30	Warnings	Name fallback generic name: HYDROCORTISONE
Thera plus Anti-itch with aloe Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	c69d0670-a65b-1680-e053-2995a90a2ee5	2023-10-26	Warnings	Name fallback generic name: HYDROCORTISONE
Assured	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	bc97f364-9443-47b8-9c2d-b5dcc00cc9b7	2023-10-25	Warnings	Name fallback generic name: HYDROCORTISONE
Thera Plus	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bcc99e5a-2403-46da-9c9d-8411fa4104e0	2023-10-25	Warnings	Name fallback generic name: HYDROCORTISONE
Family Wellness	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	cddc9c4a-7c58-4225-921a-05d6afb49178	2023-10-24	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	b33f51f5-7506-43d3-863b-406dc5c7d167	2023-07-18	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Anusol HC	HYDROCORTISONE	Salix Pharmaceuticals, Inc	5a0439c8-50a0-4f85-9cb4-9e3a5b0c31e7	2023-06-01	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Asclemed USA, Inc.	459a9907-1261-4a75-8388-f0e2f466939c	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	d50240db-f630-4008-a272-55ba5c991304	2022-07-01	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Asclemed USA, Inc.	b8437441-a4a6-4fb5-82eb-e49af69704f4	2021-04-10	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Actavis Pharma, Inc.	aa9dba84-eb38-4ec3-8555-87c948bf2384	2020-07-01	Adverse reactions	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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