Application 083365

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE	HYDROCORTISONE	TABLET;ORAL	20MG	No	No
002	HYDROCORTISONE	HYDROCORTISONE	TABLET;ORAL	5MG	No	No
003	HYDROCORTISONE	HYDROCORTISONE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A083365-001	HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982
A083365-002	HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23
A083365-003	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL		2015-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL		2015-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	Approved before 1982		`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A083365-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083365-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083365-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A083365-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083365-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083365-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083365-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083365-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083365-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083365-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083365-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083365-003	AB	1	`ea99ee380514…`

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 14 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	ab95e606-69f0-1d58-e053-2a95a90a073b	2024-12-20	Warnings	Name fallback brand name: Hydrocortisone
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	9a23c992-2df9-4bef-9409-47805eecfacd	2024-12-18	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	9ef5a3b2-c36f-162f-e053-2995a90ae2b0	2024-12-18	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	c58904b5-ec72-4cf6-e053-2a95a90a2bfc	2024-12-18	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	0a5a35be-9e21-18dd-e063-6394a90a097f	2024-12-18	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone 1% with healing aloe	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	0d3321fe-1848-4928-a3cc-d33a8d599977	2024-12-18	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone 1%	HYDROCORTISONE	Geri-Care Pharmaceuticals, Corp	fd67566a-1076-019d-e053-6394a90a415c	2024-12-17	Warnings	Name fallback generic name: HYDROCORTISONE
Audiologist Anti-itch	HYDROCORTISONE	OAKTREE PRODUCTS, INC.	853e078e-1e91-d55f-e053-2991aa0a6dcd	2024-12-13	Warnings	Name fallback generic name: HYDROCORTISONE
CVS Anti itch	HYDROCORTISONE	CVS	884df604-711b-4a3d-e053-2995a90a3a04	2024-12-13	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	J&A Digital Inc.	ff95a536-35b3-4006-b43c-cce359e86aa9	2024-12-10	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Post Treatment Balm	HYDROCORTISONE	Allure Labs Inc.	faa803e6-453c-4d86-85dd-5a5dcdd72d02	2024-12-05	Warnings	Name fallback generic name: HYDROCORTISONE
CliniCalm	HYDROCORTISONE	CP Skin Health Group, Inc.	febcf7e8-668c-a5c9-e053-6394a90aec39	2024-12-03	Warnings	Name fallback generic name: HYDROCORTISONE
First Aid Only Hydrocortisone 1% Anti-Itch	HYDROCORTISONE	Acme United Corporation	e5597b11-b08e-99e1-e053-2a95a90a15a5	2024-11-19	Warnings	Name fallback generic name: HYDROCORTISONE
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	c6b9c4e1-bab8-490d-8c00-c43377ad0857	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Walgreen Company	1a9b8b4c-3e15-49e6-af91-76ed0dc0829e	2024-11-15	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	d1ac686e-62f2-4177-8abc-8c7ca578de1a	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
basic care hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	a0d0e82b-03ff-4d43-9be0-0e414ee49970	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
DG health hydrocortisone	HYDROCORTISONE	Dolgencorp, LLC	40710bae-32bb-47fd-b3dd-31d2c98ee70f	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
careone anti itch	HYDROCORTISONE	American Sales Company	5f7b1435-ebee-4093-847a-79e8d6641404	2024-11-15	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	ALLIED TRADE LINK LLC	26bc238d-3bda-0c29-e063-6394a90a35fb	2024-11-12	Warnings	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1252	Hydrocortisone	Hydrocortisone	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1253	Hydrocortisone	Hydrocortisone	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1254	Hydrocortisone	Hydrocortisone	West-Ward Pharmaceuticals Corp	ANDA	Current
0904-2674	Hydrocortisone	Hydrocortisone	Major Pharmaceuticals	ANDA	Current
43063-386	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current