Application 213876

Type: NDA
Sponsor: DIURNAL LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALKINDI SPRINKLE	HYDROCORTISONE	CAPSULE;ORAL	0.5MG	No	No
002	ALKINDI SPRINKLE	HYDROCORTISONE	CAPSULE;ORAL	1MG	No	No
003	ALKINDI SPRINKLE	HYDROCORTISONE	CAPSULE;ORAL	2MG	No	No
004	ALKINDI SPRINKLE	HYDROCORTISONE	CAPSULE;ORAL	5MG	No	No

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

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	Approval date
N213876-001	ALKINDI SPRINKLE	HYDROCORTISONE	0.5MG	GRANULE / ORAL	RLD	2020-09-29
N213876-002	ALKINDI SPRINKLE	HYDROCORTISONE	1MG	GRANULE / ORAL	RLD	2020-09-29
N213876-003	ALKINDI SPRINKLE	HYDROCORTISONE	2MG	GRANULE / ORAL	RLD	2020-09-29
N213876-004	ALKINDI SPRINKLE	HYDROCORTISONE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213876-001	9717740	2032-11-19	U-3075		2021-03-03
N213876-001	9675559	2033-01-10	U-3075		2021-03-03
N213876-001	9649280	2034-05-12	U-3075	Drug product	2021-03-03
N213876-002	9717740	2032-11-19	U-3075		2021-03-03
N213876-002	9675559	2033-01-10	U-3075		2021-03-03
N213876-002	9649280	2034-05-12	U-3075	Drug product	2021-03-03
N213876-003	9717740	2032-11-19	U-3075		2021-03-03
N213876-003	9675559	2033-01-10	U-3075		2021-03-03
N213876-003	9649280	2034-05-12	U-3075	Drug product	2021-03-03
N213876-004	9717740	2032-11-19	U-3075		2021-03-03
N213876-004	9675559	2033-01-10	U-3075		2021-03-03
N213876-004	9649280	2034-05-12	U-3075	Drug product	2021-03-03

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 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213876-001	ALKINDI SPRINKLE	0.5MG	GRANULE / ORAL	RLD	2020-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213876-002	ALKINDI SPRINKLE	1MG	GRANULE / ORAL	RLD	2020-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213876-003	ALKINDI SPRINKLE	2MG	GRANULE / ORAL	RLD	2020-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213876-004	ALKINDI SPRINKLE	5MG	GRANULE / ORAL	RLD, RS	2020-09-29	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213876-001	9717740	2032-11-19	U-3075		2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-001	9675559	2033-01-10	U-3075		2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-001	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-002	9717740	2032-11-19	U-3075		2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-002	9675559	2033-01-10	U-3075		2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-002	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-003	9717740	2032-11-19	U-3075		2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-003	9675559	2033-01-10	U-3075		2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-003	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-004	9717740	2032-11-19	U-3075		2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-004	9675559	2033-01-10	U-3075		2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213876-004	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213876-001	9717740	2032-11-19	U-3075		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-001	9675559	2033-01-10	U-3075		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-001	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-002	9717740	2032-11-19	U-3075		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-002	9675559	2033-01-10	U-3075		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-002	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-003	9717740	2032-11-19	U-3075		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-003	9675559	2033-01-10	U-3075		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-003	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-004	9717740	2032-11-19	U-3075		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-004	9675559	2033-01-10	U-3075		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213876-004	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-001	9717740	2032-11-19	U-3075		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-001	9675559	2033-01-10	U-3075		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-001	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-002	9717740	2032-11-19	U-3075		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-002	9675559	2033-01-10	U-3075		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-002	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-003	9717740	2032-11-19	U-3075		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-003	9675559	2033-01-10	U-3075		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-003	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-004	9717740	2032-11-19	U-3075		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-004	9675559	2033-01-10	U-3075		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213876-004	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213876-001	9717740	2032-11-19	U-3075		2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213876-001	9675559	2033-01-10	U-3075		2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213876-001	9649280	2034-05-12	U-3075	Drug product	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213876-002	9717740	2032-11-19	U-3075		2021-03-03	`6a471c1ec25d…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alkindi Sprinkle	HYDROCORTISONE	Eton Pharmaceuticals, Inc.	26c13a5f-7119-4c6a-bf10-fda4e07d7682	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213876 application number: NDA213876 ndc (product): 71863-109 ndc (product): 71863-111 ndc (product): 71863-112 ndc (product): 71863-110

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71863-109	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-109	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-109	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-109	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-109	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-110	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-110	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-110	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-110	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-110	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-111	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-111	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-111	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-111	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-111	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-112	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-112	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-112	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-112	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current
71863-112	Alkindi	Hydrocortisone	Eton Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78729	SUPPL	2024-07-02
78668	SUPPL	2024-06-06
78667	SUPPL	2024-06-06
73052	SUPPL	2022-12-27
73044	SUPPL	2022-12-27
73043	SUPPL	2022-12-27
70098	SUPPL	2022-02-07
70097	SUPPL	2022-02-07
70084	SUPPL	2022-02-04
68655	ORIG	2021-09-20
64773	ORIG	2020-10-01
64764	ORIG	2020-09-30