Application 040396

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	2.5%	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
A040396-001	MICORT-HC	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL			2001-02-27

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	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040396-001	MICORT-HC	2.5%	CREAM / TOPICAL	2001-02-27	`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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone Acetate Cream	HYDROCORTISONE ACETATE CREAM	Allegis Pharmaceuticals, Inc.	57c6aadb-fa88-044f-e063-6394a90a3db8	2026-07-29	Adverse reactions	Exact identifier application applno (ANDA): 040396 application number: ANDA040396
Hydrocortisone Acetate Cream	HYDROCORTISONE ACETATE CREAM	Allegis Holdings LLC	3b008546-afa5-fe5a-e063-6394a90adb3b	2025-07-28	Adverse reactions	Exact identifier application applno (ANDA): 040396 application number: ANDA040396

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54766-835	MiCort HC	hydrocortisone acetate	Sebela Pharmaceuticals Inc.	ANDA	Current
54766-835	MiCort HC	hydrocortisone acetate	Sebela Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
29948	ORIG	2001-02-27