Application 040259

Type: ANDA
Sponsor: FERNDALE LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE ACETATE	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
A040259-001	HYDROCORTISONE ACETATE	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL			1999-07-29

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	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040259-001	HYDROCORTISONE ACETATE	2.5%	CREAM / TOPICAL	1999-07-29	`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 3 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	APNAR PHARMA LP	cb60f2a6-8bab-c0f9-e053-2a95a90a422a	2022-03-16	Adverse reactions	Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Patrin Pharma Inc.	7c1d2c8c-26e2-432f-b983-505f259665a9	2021-12-22	Adverse reactions	Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Proficient Rx LP	43ed7a9a-0aaf-4987-8367-e2490d1b8448	2020-05-07	Adverse reactions	Name fallback brand name: Hydrocortisone Acetate 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
42602	ORIG	1999-07-29
7593	ORIG	1999-07-29