Application 080776

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	CORTISONE ACETATE	CORTISONE ACETATE	TABLET;ORAL	25MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080776-002	CORTISONE ACETATE	CORTISONE ACETATE	25MG	TABLET / ORAL		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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080776-002	CORTISONE ACETATE	25MG	TABLET / ORAL	RS, Approved before 1982	`e64feba35796…`

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortisone Acetate	CORTISONE ACETATE	Chartwell RX, LLC	cc158d11-f356-4696-8b73-5d2681dcbcf2	2025-06-06	Warnings, Adverse reactions	Name fallback brand name: Cortisone Acetate generic name: CORTISONE ACETATE
Cortisone aceticum	CORTISONE ACETATE	Boiron	68f7a30a-e372-6ee9-e053-2a91aa0a6ddf	2023-11-13		Name fallback generic name: CORTISONE ACETATE
Cortisone aceticum	CORTISONE ACETATE	Boiron	85424b40-5c2b-421d-e053-2991aa0a7771	2023-11-13		Name fallback generic name: CORTISONE ACETATE
Cortisone aceticum	CORTISONE ACETATE	Boiron	85426060-5630-aaa0-e053-2a91aa0af8d4	2023-04-11		Name fallback generic name: CORTISONE ACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1202	Cortisone Acetate	Cortisone Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1202	Cortisone Acetate	Cortisone Acetate	West-ward Pharmaceutical Corp	ANDA	Current
0143-1202	Cortisone Acetate	Cortisone Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9700	Cortisone Acetate	Cortisone Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9700	Cortisone Acetate	Cortisone Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9700	Cortisone Acetate	Cortisone Acetate	West-Ward Pharmaceuticals Corp	ANDA	Current
59115-161	CORTISONE ACETATE	CORTISONE ACETATE	Hikma Pharmaceutical	ANDA	Current