Application 087315

Type: ANDA
Sponsor: ALPHARMA US PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE	HYDROCORTISONE	LOTION;TOPICAL	1%	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
A087315-001	HYDROCORTISONE	HYDROCORTISONE	1%	LOTION / TOPICAL			1982-06-07

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	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087315-001	HYDROCORTISONE	1%	LOTION / TOPICAL	1982-06-07	`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 18 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
astonea	HYDROCORTISONE	ASTONEA LABS PRIVATE LIMITED	de09e859-c5fd-0cc5-e053-2a95a90a147e	2024-06-25	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Aurobindo Pharma Limited	6d820911-f50e-46a4-8174-c4ee89f6792e	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	720357e2-6f01-737d-e053-2a95a90ae54b	2024-06-10	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone 1%	HYDROCORTISONE	Chain Drug Marketing Association Inc.	1c834ba0-86b6-8e61-e063-6394a90a192d	2024-06-04	Warnings	Name fallback generic name: HYDROCORTISONE
MyMedic Hydrocortisone	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	197fc623-2fb9-184c-e063-6394a90a4104	2024-05-28	Warnings	Name fallback generic name: HYDROCORTISONE
TheraCare Hydrocortisone Cream	HYDROCORTISONE	Veridian Healthcare	01cb7b47-2c3c-707d-e063-6294a90a5d97	2024-05-21	Warnings	Name fallback generic name: HYDROCORTISONE
THERAPLEX AIM Anti-Itch Moisturizing	HYDROCORTISONE	THERAPLEX, LLC	d1b231b6-cc9f-488a-9121-501831473772	2024-04-27	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE ACETATE	JHK Inc dba American Safety & First Aid	64adc8d0-7ca4-4c1a-813f-f1df47e916f2	2024-04-25	Warnings	Name fallback brand name: HYDROCORTISONE
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Cardinal Health 110 dba LEADER	16f2f3cb-4611-5867-e063-6394a90af107	2024-04-25	Warnings	Name fallback generic name: HYDROCORTISONE
Anti Itch	HYDROCORTISONE	Neilmed Pharmaceuticals Inc.	14b4f066-fde4-ac97-e063-6394a90ae64c	2024-04-20	Warnings	Name fallback generic name: HYDROCORTISONE
Walgreens Scalp Relief External analgesic	HYDROCORTISONE	Walgreen Company	da0a24c7-9295-4f22-b2c7-40000dad4b81	2024-04-18	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	a2c18606-631f-4e89-8936-3d635a41c37d	2024-04-03	Adverse reactions	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	141aa2a7-8789-1127-e063-6294a90a2d23	2024-03-20	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Cortisol	HYDROCORTISONE	Deseret Biologicals, Inc.	32ae980b-5a01-4d08-885a-1c0a8fbfbb2e	2024-03-06	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	848574fe-a23e-4e15-8c29-d624f50b71de	2024-03-01	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	2999fecb-cb15-4023-ade4-ab5822b094d5	2024-02-29	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
PREPARATION H HYDROCORTISONE	HYDROCORTISONE	Haleon US Holdings LLC	b8d531eb-4012-0450-0e4b-70a808464041	2024-02-29	Warnings	Name fallback generic name: HYDROCORTISONE
Maximum Strength Scalp Itch Relief Anti-itch	HYDROCORTISONE	Rite Aid	55569563-fc38-4f97-8e74-9f96e3173384	2024-02-28	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE ACETATE	HART Health	779f945f-ab69-40de-8d86-ab76debc5c7c	2024-02-16	Warnings	Name fallback brand name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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