Application 040398

Type: ANDA
Sponsor: SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICORT-HC	HYDROCORTISONE ACETATE	CREAM;TOPICAL	2%	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
A040398-001	MICORT-HC	HYDROCORTISONE ACETATE	2%	CREAM / TOPICAL			2002-03-29

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	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040398-001	MICORT-HC	2%	CREAM / TOPICAL	2002-03-29	`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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	NuCare Pharmaceuticals,Inc.	af1142eb-553e-7686-e053-2a95a90a0f9a	2024-07-17	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Anusol HC	HYDROCORTISONE ACETATE	Salix Pharmaceuticals, Inc	a562f3d7-2692-4357-aade-ae50afcbfddd	2024-07-01	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Cortifoam	HYDROCORTISONE ACETATE	Viatris Specialty LLC	0093b694-9fcb-46ae-b1ab-7d0fa204c6c8	2024-05-15	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
HYDROCORTISONE	HYDROCORTISONE ACETATE	JHK Inc dba American Safety & First Aid	64adc8d0-7ca4-4c1a-813f-f1df47e916f2	2024-04-25	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Walgreens Eczema Relief	HYDROCORTISONE ACETATE	Walgreen Co.	4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c	2024-02-28	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Rising Pharma Holdings, Inc.	de171b0a-3854-4aaa-889e-f2d999c0458c	2024-02-20	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
HYDROCORTISONE	HYDROCORTISONE ACETATE	HART Health	779f945f-ab69-40de-8d86-ab76debc5c7c	2024-02-16	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Medi-First Hydrocortisone 1%	HYDROCORTISONE ACETATE	Unifirst First Aid Corporation	bd216f5d-f304-7d8d-e053-2a95a90aa9ce	2024-01-17	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cfde0-c463-e9b5-e053-2a95a90a1924	2024-01-15	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cce4b-c70a-1b2d-e053-2995a90aa4aa	2024-01-15	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Bryant Ranch Prepack	172e225e-9a00-4a5c-b209-8f3fa6b58d0f	2024-01-11	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Bryant Ranch Prepack	653fa10e-ab54-4b14-9ffa-8fd95b5e1040	2024-01-11	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Poli-A	HYDROCORTISONE ACETATE	Sato Pharmaceutical Co., Ltd.	e27a3840-d9de-4bd0-ad75-8a151bd12b83	2023-11-28	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Cosette Pharmaceuticals, Inc.	c84ab549-1d5c-4646-a041-6cb571812ad8	2023-11-23	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
ANUCORT-HC	HYDROCORTISONE ACETATE	Cosette Pharmaceuticals, Inc.	f0f5a107-1236-8e1a-815d-dec8007c2bc9	2023-11-22	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Bentlin Products LLC	4346351c-8e11-46ae-b428-98d17f55beb9	2023-10-30	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
HYDROCORTISONE ACETATE	HYDROCORTISONE ACETATE	Nivagen Pharmaceuticals, Inc.	7743779d-1e42-4b23-bde5-0d77fe95bb2b	2023-08-28	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	QUAGEN PHARMACEUTICALS LLC	60dce400-1138-4781-b621-1774c0dbb64a	2023-05-17	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	A-S Medication Solutions	03321951-e338-4955-8622-0f5ea29c6cd9	2023-01-18	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Padagis US LLC	2fdb9940-6da8-49b0-a236-9817943f7a4b	2022-05-31	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7647	ORIG	2003-04-08