Application 216013

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	TABLET;ORAL	0.1MG	No	No

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
A216013-001	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL			2022-10-27

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-10-27	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216013-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL		2022-10-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A216013-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216013-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216013-001	AB	1	`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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Major Pharmaceuticals	933e28ef-05e8-419e-a786-21eab67f33a2	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Cardinal Health 107, LLC	89b5687a-6e21-47cd-9c05-d9c9f4f8cf49	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
fludrocortisone acetate	FLUDROCORTISONE ACETATE	Eywa Pharma Inc	eff2eae8-94ce-46ca-a027-6b1d08e7b96b	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: fludrocortisone acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Cardinal Health 107, LLC	3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da7	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NCS HealthCare of KY, LLC dba Vangard Labs	3c007f9a-4cd5-4e74-a633-d55dde1fe903	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	AvKARE	b8ce5b7e-7aa2-45f8-e053-2995a90a6c65	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvPAK	2cd3965d-cab9-a97c-db61-7d03ced154f3	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: FLUDROCORTISONE ACETATE generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals of New York LLC	4ed382df-f2d5-46a4-a68b-aba807777093	2025-12-20	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone acetate	FLUDROCORTISONE ACETATE	Golden State Medical Supply, Inc.	3752ff25-8887-5c88-e063-6294a90a345a	2025-08-29	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	American Health Packaging	001e72ea-2c9e-468c-90cc-6c347234e2a9	2025-05-19	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone acetate	FLUDROCORTISONE ACETATE	Zydus Lifesciences Limited	6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Bryant Ranch Prepack	3d6f1a89-ea11-474d-aaca-64fea02a3beb	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone acetate	FLUDROCORTISONE ACETATE	Viona Pharmaceuticals Inc	bc92f5c6-3a65-4fab-85b3-fd5b84f917c1	2024-07-13	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals NY LLC	51363453-6d33-4aee-8426-37ac0bf3cc10	2024-02-09	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NorthStar Rx LLC	04ad6ba3-6781-b5df-e063-6294a90a7e6e	2023-09-07	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Novitium Pharma LLC	96dbbf53-962b-49a4-a60d-91ae0b9fb9ff	2022-06-03	Warnings, Adverse reactions	Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE