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 17 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Anti Itch	HYDROCORTISONE	Safeway	ed0eb068-3ce6-423d-a7f8-c3456b7f6040	2024-09-23	Warnings	Name fallback generic name: HYDROCORTISONE
members mark hydrocortisone	HYDROCORTISONE	Sam's West Inc	218f0dcd-fa67-4935-8019-ecbbd53ed2f7	2024-09-23	Warnings	Name fallback generic name: HYDROCORTISONE
anti itch	HYDROCORTISONE	Meijer, Inc.	a07496e0-6fc2-4190-8a01-f513134ffb92	2024-09-23	Warnings	Name fallback generic name: HYDROCORTISONE
Exchange Select Hydrocortisone	HYDROCORTISONE	Army & Air Force Exchange Service	1b709db3-7dc1-4756-a8a0-dddda875dc57	2024-09-19	Warnings	Name fallback generic name: HYDROCORTISONE
anti itch	HYDROCORTISONE	Meijer, Inc.	00040bfe-001a-484e-bec0-e21e8b27f369	2024-09-17	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0ae1ba79-3992-4910-b03f-6f9b0f26e300	2024-09-12	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Itch and Rash Cream	HYDROCORTISONE	Wildman Business Group	1f95757d-a434-f02a-e063-6294a90a2d12	2024-09-01	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	84c95149-9064-4b4d-a7d0-93dfefca1370	2024-08-22	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
CVS Health Maximum Strength Scalp Relief Anti-itch	HYDROCORTISONE	CVS Health	b5ef0005-8b76-4205-8be0-db3a7ed7d1c4	2024-08-19	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	5bb279c6-d572-43a2-e053-2991aa0a686e	2024-08-14	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	fbbbcc67-b46d-d41a-e053-6294a90aa55d	2024-08-08	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	e64cae82-fd7b-47c8-ada9-4dcb283f1d1f	2024-08-07	Adverse reactions	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
CVS Health Hydrocortisone Anti Itch	HYDROCORTISONE	CVS Health	546a1b8a-8254-432a-85c4-38ebee5ad568	2024-08-07	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	e1166b3a-a304-4030-ab51-eb55c6e91afd	2024-08-01	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	2dda4f32-e0f6-4e8d-8d75-10da5b762790	2024-07-22	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	47bfae62-bf25-413e-93fc-3c72c901f1a5	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	ac3947c9-5a66-b4e7-e053-2995a90a6f67	2024-07-17	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	6c676166-2471-478c-b662-f8c9c168977b	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	134fae59-f928-4304-86ca-2271b593caf4	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Amneal Pharmaceuticals of New York LLC	9fe627ad-4aba-4bd1-8590-6cc2d61674ba	2024-07-03	Warnings, Adverse reactions	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