Application 078556

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIGOXIN	DIGOXIN	TABLET;ORAL	0.125MG	No	No
002	DIGOXIN	DIGOXIN	TABLET;ORAL	0.25MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078556-001	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL			2009-07-20
A078556-002	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL			2009-07-20

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 3 · 84 observed 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	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL		2009-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL		2009-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL		2009-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL		2009-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL		2009-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL		2009-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL		2009-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL		2009-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL		2009-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL		2009-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL		2009-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL		2009-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL		2009-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL		2009-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078556-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2009-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078556-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2009-07-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078556-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078556-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078556-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078556-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078556-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078556-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078556-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078556-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078556-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078556-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078556-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078556-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078556-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078556-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078556-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078556-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078556-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078556-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078556-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078556-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078556-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078556-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078556-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078556-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078556-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078556-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078556-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078556-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078556-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078556-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078556-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078556-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078556-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078556-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078556-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078556-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078556-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078556-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078556-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078556-002	AB	1	`b00525d2431f…`

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
Digoxin	DIGOXIN	Amneal Pharmaceuticals of New York LLC	dfac7f13-28be-423d-9389-9089da29da17	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078556 application number: ANDA078556 ndc (product): 0115-9811 ndc (product): 0115-9822

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-9811	Digoxin	DIGOXIN	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9811	Digoxin	DIGOXIN	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9811	Digoxin	DIGOXIN	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9811	Digoxin	DIGOXIN	Impax Generics	ANDA	Current
0115-9822	Digoxin	DIGOXIN	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9822	Digoxin	DIGOXIN	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9822	Digoxin	DIGOXIN	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9822	Digoxin	DIGOXIN	Impax Generics	ANDA	Current
53808-0699	Digoxin	DIGOXIN	State of Florida DOH Central Pharmacy	ANDA	Current
68084-366	Digoxin	DIGOXIN	American Health Packaging	ANDA	Current
68084-366	Digoxin	DIGOXIN	American Health Packaging	ANDA	Current
68084-366	Digoxin	DIGOXIN	American Health Packaging	ANDA	Current
68084-680	Digoxin	DIGOXIN	American Health Packaging	ANDA	Current
68084-680	Digoxin	DIGOXIN	American Health Packaging	ANDA	Current
68084-680	Digoxin	DIGOXIN	American Health Packaging	ANDA	Current
71335-1052	Digoxin	DIGOXIN	Bryant Ranch Prepack	ANDA	Current
71335-1052	Digoxin	DIGOXIN	Bryant Ranch Prepack	ANDA	Current