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 19 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No Mess Hydrocortisone Applicator	HYDROCORTISONE	Walgreen Co.	cfefb517-9099-41c4-8a95-74414ca4032c	2024-02-16	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	ccb62898-b614-45b9-95ea-23e5e31893a8	2024-02-01	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone with Aloe	HYDROCORTISONE	Proficient Rx LP	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	2024-02-01	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	c57d5f8e-5934-4cbb-999a-cdd55e5b105f	2024-02-01	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Proficient Rx LP	47e9fe84-bd0c-40ea-85de-e950bcacc557	2024-02-01	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	Dynarex Corporation	81dff9df-6f7e-49f0-e053-2a91aa0af7e7	2024-01-23	Warnings	Name fallback brand name: Hydrocortisone
Green Guard Hydrocortisone 1%	HYDROCORTISONE	Unifirst First Aid Corporation	bd348e2a-57b1-3f17-e053-2a95a90a8bdc	2024-01-17	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	c4013d86-e134-43c3-ad75-7e680a9d2ae7	2024-01-11	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	f05b7fa6-26a9-4aca-8975-819ece891060	2023-12-31	Adverse reactions	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
CeraVe Developed with Dermatologists Anti Itch	HYDROCORTISONE	L'Oreal USA Products Inc.	8d65e945-2557-486f-9279-ecbaa08f31c4	2023-12-31	Warnings	Name fallback generic name: HYDROCORTISONE
Petrocort Antipruritic Lip 21	HYDROCORTISONE	Clinical Formula LLC	7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b	2023-12-15	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE 1%	Weeks & Leo Co., Inc.	0c5325e3-4796-856c-e063-6394a90a1f90	2023-12-12	Warnings	Name fallback brand name: Hydrocortisone
Westlake Anti-itch	HYDROCORTISONE	Westlake Pharma LLC	0c53c982-3f23-a2d5-e063-6394a90acd55	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Rite Aid Anti-itch	HYDROCORTISONE	Rite Aid	0c540422-1579-9217-e063-6294a90ad06a	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Anti-itch Paraben Free	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c5419c5-0929-7ca6-e063-6294a90ac0a7	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Anti itch	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c58b750-d3a6-5ed1-e063-6294a90a4321	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Quatriderm Anti-itch	HYDROCORTISONE	OPMX LLC	83e59e10-9878-e5c2-e053-2a91aa0af25e	2023-12-04	Warnings	Name fallback generic name: HYDROCORTISONE
Bloop Itch Soothing Topical	HYDROCORTISONE	Three Nations Corp	0b64677e-d4bf-0929-e063-6294a90af137	2023-11-30	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5ee2f62a-d8d5-4efd-bf6f-f79c10855631	2023-11-22	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	b505769e-9c46-3cf3-e053-2a95a90a4df9	2023-11-17	Warnings	Name fallback brand 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