Application 040431

Type: ANDA
Sponsor: IMPAX LABS

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	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040431-001	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040431-001	AB

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040431-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040431-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040431-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040431-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040431-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040431-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040431-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040431-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040431-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040431-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040431-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040431-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040431-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040431-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040431-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040431-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040431-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040431-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040431-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040431-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040431-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040431-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040431-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040431-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040431-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040431-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040431-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040431-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040431-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040431-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040431-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040431-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040431-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040431-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040431-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040431-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040431-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040431-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040431-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040431-001	AB	1	`cb3db0bc1861…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Cardinal Health 107, LLC	89b5687a-6e21-47cd-9c05-d9c9f4f8cf49	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431 ndc (product): 55154-6645
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NCS HealthCare of KY, LLC dba Vangard Labs	3c007f9a-4cd5-4e74-a633-d55dde1fe903	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431 ndc (product): 0615-6562
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	AvKARE	b8ce5b7e-7aa2-45f8-e053-2995a90a6c65	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431 ndc (product): 42291-764
FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvPAK	2cd3965d-cab9-a97c-db61-7d03ced154f3	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431 ndc (product): 50268-330
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals of New York LLC	4ed382df-f2d5-46a4-a68b-aba807777093	2025-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431 ndc (product): 0115-7033
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	American Health Packaging	001e72ea-2c9e-468c-90cc-6c347234e2a9	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431 ndc (product): 68084-288
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals NY LLC	51363453-6d33-4aee-8426-37ac0bf3cc10	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431 ndc (product): 69238-7033

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-7033	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Impax Generics	ANDA	Current
0115-7033	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-7033	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Impax Generics	ANDA	Current
0115-7033	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-7033	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-7033	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-7033	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0615-6562	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6562	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42291-529	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvKARE, Inc.	ANDA	Current
42291-529	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvKARE, Inc.	ANDA	Current
42291-529	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvKARE	ANDA	Current
42291-764	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	AvKARE	ANDA	Current
42291-764	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	AvKARE	ANDA	Current
50268-330	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvPAK	ANDA	Current
50268-330	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvPAK	ANDA	Current
50268-330	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvPAK	ANDA	Current
50268-330	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvPAK	ANDA	Current
55154-6645	Fludrocortisone Acetate	Fludrocortisone Acetate	Cardinal Health	ANDA	Current
55154-6645	Fludrocortisone Acetate	Fludrocortisone Acetate	Cardinal Health	ANDA	Current
55154-6645	Fludrocortisone Acetate	Fludrocortisone Acetate	Cardinal Health	ANDA	Current
55154-6645	Fludrocortisone Acetate	Fludrocortisone Acetate	Cardinal Health	ANDA	Current
55154-6645	Fludrocortisone Acetate	Fludrocortisone Acetate	Cardinal Health 107, LLC	ANDA	Current
68084-288	Fludrocortisone Acetate	Fludrocortisone Acetate	American Health Packaging	ANDA	Current
68084-288	Fludrocortisone Acetate	Fludrocortisone Acetate	American Health Packaging	ANDA	Current
68084-288	Fludrocortisone Acetate	Fludrocortisone Acetate	American Health Packaging	ANDA	Current
68084-288	Fludrocortisone Acetate	Fludrocortisone Acetate	American Health Packaging	ANDA	Current
69238-7033	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-7033	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals NY LLC	ANDA	Current
71335-0976	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Bryant Ranch Prepack	ANDA	Current
71335-0976	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Bryant Ranch Prepack	ANDA	Current
71335-0976	Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7660	ORIG	2003-04-09