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 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL	AB		2015-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL	AB		2015-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL			2015-02-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083365-003	HYDROCORTISONE	10MG	TABLET / ORAL			2015-02-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083365-001	HYDROCORTISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083365-002	HYDROCORTISONE	5MG	TABLET / ORAL	AB		2015-02-23	`3f01610625f2…`

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 1 of 20 · 389 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Cortisone Liquid	HYDROCORTISONE	CVS Pharmacy	42df45a9-d449-090a-e063-6394a90a9ee4	2026-09-01	Warnings	Name fallback generic name: HYDROCORTISONE
Terramed Just Think Comfort Hydrocortisone 1% Cream	HYDROCORTISONE	Rida LLC	0d2c0c2c-370f-4adb-b0ea-1e218c927f8b	2026-09-01	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	American Health Packaging	506aab0d-9308-4d60-90b3-7d64952fff36	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin	HYDROCORTISONE	AmerisourceBergen	c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495	2026-08-30	Warnings	Name fallback generic name: HYDROCORTISONE
Gembooxt ECZEMA RELIEF Cream	HYDROCORTISONE	Guangdong Quadrant Ecological Technology Co., Ltd.	46490d65-f789-eaa2-e063-6294a90a623b	2026-08-27	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	5f87d7fb-f258-48b0-8b60-1055e22ebd71	2026-08-25	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
ANTI ITCH	HYDROCORTISONE	HyVee Inc	1ab6bbb8-2b91-4c53-9168-b1e85ac296e9	2026-08-19	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone 1	HYDROCORTISONE	Kroger Company	f05edff2-2dc5-427c-b52c-518e0aaef4e0	2026-08-19	Warnings	Name fallback generic name: HYDROCORTISONE
MedPride	HYDROCORTISONE	Shield Line LLC	2f15d3b3-d1e6-4742-9eac-f956c0ffbba4	2026-08-18	Warnings	Name fallback generic name: HYDROCORTISONE
JJ Care	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	c88fa151-f8a8-4de2-98c9-71319bf53e36	2026-08-13	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Safetec of America, Inc.	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	2026-08-13	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Amazon.com Services LLC	f40b4223-e81f-4cd0-bc9b-d3d33ce8cce5	2026-08-12	Warnings	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Solco Healthcare LLC	04f112e5-ec88-46c8-b675-8b4e38a86ab4	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone with Aloe	HYDROCORTISONE	TARGET Corporation	4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5	2026-08-11	Warnings	Name fallback generic name: HYDROCORTISONE
Instant Cooling Itch Relief	HYDROCORTISONE	CVS Pharmacy	46545d04-5958-d136-e063-6394a90a3462	2026-08-07	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	2026-08-04	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	REMEDYREPACK INC.	f0e66726-946b-4f63-b457-2851dc69e6b4	2026-08-03	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Eywa Pharma Inc	b3f06d10-2f01-428c-88a4-505c61c87ce8	2026-07-25	Warnings, Adverse reactions	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
AEROSOOTHE	HYDROCORTISONE	Aero Healthcare US LLC	22b172a2-07e8-4ebb-b0a0-dfe4f25477fa	2026-07-24	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