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 5 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortenema	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	a307448a-ccc4-41a8-977a-11f28f0bded9	2026-03-02	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Procto-Med HC	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	4b972547-5bd4-155d-e063-6394a90a03ee	2026-03-02	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	40654d12-56e4-4489-be49-19c60ad918ad	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	PD-Rx Pharmaceuticals, Inc.	931ed426-89a1-4877-a4a5-cb963d51e717	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	a3fbdae4-d1dc-42de-939f-f9a7aab60e49	2026-02-24	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	9578b39e-3df7-4d75-abd7-f1d5524545e5	2026-02-23	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	bb959c6f-7c9a-43c5-a45b-2ad9a87baa88	2026-02-18	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Medrock Pharmacy LLC	43e00e17-1a48-43db-9589-834568917bbf	2026-02-17	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Natureplex Hydrocortisone Hydro	HYDROCORTISONE	Natureplex, LLC	2fc6a148-34bb-4289-8588-32c1bb011b98	2026-02-13	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE CREAM 1%	Aldermed Inc.	4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d	2026-02-10	Warnings	Name fallback brand name: Hydrocortisone
Aquanil HC	HYDROCORTISONE	Person and Covey	4a698246-05a6-d01f-e063-6294a90a3401	2026-02-09	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Sportpharm LLC	ee64ad1e-78db-4553-a3cf-b539b770fa26	2026-02-06	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	CVS PHARMACY, INC	8b8cdb26-8e8f-4e95-9d83-d685c90afe01	2026-02-02	Warnings	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c	2026-01-30	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
ProCure Hydrocortisone Cream Plus	HYDROCORTISONE	Rooftop Consumer Health, Inc.	fe334cae-e019-4397-8498-df3c923ae8b5	2026-01-29	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	bc374fa4-ac8b-408e-9321-8bab97a18770	2026-01-28	Adverse reactions	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	31fbb576-0e76-471c-83c8-9e0125bc1791	2026-01-28	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	bcd103f3-3dc8-4394-b8fd-8f8ddb721f77	2026-01-28	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone with Aloe	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	4a113699-1eb7-49b8-8cdf-2ad57db89b81	2026-01-27	Warnings	Name fallback generic name: HYDROCORTISONE
Viaderma Calm Anti-Itch	HYDROCORTISONE	VIADERMA DISTRIBUTION INC	ea281bde-a7a2-47b6-895a-5dc2924972de	2026-01-27	Warnings	Name fallback 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