Application 008126

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORTISONE ACETATE	CORTISONE ACETATE	TABLET;ORAL	25MG	No	No
002	CORTISONE ACETATE	CORTISONE ACETATE	INJECTABLE;INJECTION	25MG/ML	No	No
003	CORTISONE ACETATE	CORTISONE ACETATE	TABLET;ORAL	5MG	No	No
004	CORTISONE ACETATE	CORTISONE ACETATE	TABLET;ORAL	10MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N008126-001	CORTISONE ACETATE	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982
N008126-002	CORTISONE ACETATE	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982
N008126-003	CORTISONE ACETATE	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982
N008126-004	CORTISONE ACETATE	CORTISONE ACETATE	10MG	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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008126-001	CORTISONE ACETATE	25MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008126-002	CORTISONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008126-003	CORTISONE ACETATE	5MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008126-004	CORTISONE ACETATE	10MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`

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

Reported adverse events (FAERS/openFDA)#

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