Application 083739

Type: ANDA
Sponsor: BEL MAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE ACETATE	HYDROCORTISONE ACETATE	INJECTABLE;INJECTION	25MG/ML	No	No
002	HYDROCORTISONE ACETATE	HYDROCORTISONE ACETATE	INJECTABLE;INJECTION	50MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083739-001	HYDROCORTISONE ACETATE	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982
A083739-002	HYDROCORTISONE ACETATE	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083739-001	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083739-002	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Preferred Pharmaceuticals, Inc.	247bb729-f0b6-4325-a9f8-4b46d5cda300	2026-08-28	Adverse reactions	Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE
Claravie	HYDROCORTISONE ACETATE	Gentell LLC	598d224b-d12e-89bf-e063-6394a90a84dc	2026-08-21	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
procure	HYDROCORTISONE ACETATE	TWIN MED, LLC	2670c9c4-66ad-40e8-a08a-582b160de39d	2026-08-03	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	AARNA USA INC.	4f9709ed-4818-3d3b-e063-6394a90a0d04	2026-04-16	Adverse reactions	Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	AvPAK	d13b0bea-4c7b-4ee4-aab1-aca8cdcea7fd	2026-01-08	Adverse reactions	Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	4a543f90-d43c-4487-b27e-f43394c6320d	2026-01-04	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hemmorex-HC	HYDROCORTISONE ACETATE	Laser Pharmaceuticals, LLC	d625764a-6171-4802-9bc0-95e5785b8b7d	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
MEDI FIRST PLUS	HYDROCORTISONE ACETATE	Orazen Inc	5781124a-60f4-4a64-80b7-ce5f28d495b5	2025-12-12	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
MEDI-FIRST	HYDROCORTISONE ACETATE	Orazen Inc	aeffd85c-58a7-4d64-bf94-977b6fbbe713	2025-12-12	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate Antipruritic (Anti-Itch)	HYDROCORTISONE ACETATE	Sun Pharmaceutical Industries, Inc.	9f0b09e7-6cfd-4fd6-8631-67799edf4e08	2025-12-02	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Marlex Pharmaceuticals, Inc.	e60473f7-fd00-a477-e053-2a95a90ad4dd	2025-11-13	Adverse reactions	Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Major Pharmaceuticals	1281a82d-df00-4421-9c0d-951f8f9a9422	2025-08-05	Adverse reactions	Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE
Hydrocortisone	HYDROCORTISONE ACETATE	Rite Aid Corporation	cb6e0bed-2ea1-49d2-89e7-2554e7565b74	2025-07-11	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone	HYDROCORTISONE ACETATE	Walgreen Company	bff322f1-59c3-41e0-8685-fcfe52bf4b42	2025-07-10	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
HYDROCORTISONE ACETATE	HYDROCORTISONE ACETATE	Golden State Medical Supply, Inc.	fe42cde7-b3ac-2014-e053-6394a90a0f67	2025-02-24	Adverse reactions	Name fallback brand name: HYDROCORTISONE ACETATE generic name: HYDROCORTISONE ACETATE
Hemmorex-HC	HYDROCORTISONE ACETATE	Laser Pharmaceuticals, LLC	db67f724-c78c-4280-9c2e-6abbaeaef42d	2025-01-23	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula	HYDROCORTISONE ACETATE	Combe Incorporated	9b69fa24-02dd-43e4-a81f-9a37968d7099	2024-12-12	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Westminster Pharmaceuticals, LLC	3a29006f-9124-45e7-84a2-48f08bbb5f9c	2024-12-04	Adverse reactions	Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE
Proctocort	HYDROCORTISONE ACETATE	Salix Pharmaceuticals, Inc	a2e1222a-ab91-4382-a210-7dfdd6de1407	2024-09-17	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Anti-Itch Vulva Cream 1 Hydrocortisone Acetate	HYDROCORTISONE ACETATE	The Honey Pot Company LLC	6f32b536-6ebf-49a8-abb6-2a1daae2f6d7	2024-08-01	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE

Reported adverse events (FAERS/openFDA)#

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