Application 077002

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIGOXIN	DIGOXIN	TABLET;ORAL	0.25MG	No	No
002	DIGOXIN	DIGOXIN	TABLET;ORAL	0.125MG	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
A077002-001	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB		2007-10-30
A077002-002	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB		2007-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077002-001	AB
A077002-002	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 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	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077002-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077002-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077002-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077002-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077002-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077002-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077002-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077002-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077002-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077002-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077002-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077002-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077002-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077002-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077002-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077002-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077002-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077002-002	AB	1	`bb7c543d1eb4…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	NCS HealthCare of KY, LLC dba Vangard Labs	5886e233-b2da-4acb-be05-9bf40fb8e7f4	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002 ndc (product): 0615-8202
Digoxin	DIGOXIN	Golden State Medical Supply, Inc.	2636527a-1ecd-455f-a928-19549ac83fa1	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002 ndc (product): 60429-100 ndc (product): 60429-099
Digoxin	DIGOXIN	Cardinal Health 107, LLC	51925501-ab5b-4e12-a67e-ec2b4b592e83	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002 ndc (product): 55154-5882
Digoxin	DIGOXIN	Major Pharmaceuticals	48cad559-c17b-4d41-a154-e664e958c1c0	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002 ndc (product): 0904-5921 ndc (product): 0904-5922
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	41c16cff-b03e-405e-a617-d6f45d3ce2bd	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002 ndc (product): 0143-1241 ndc (product): 0143-1240

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1240	Digoxin	Digoxin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1240	Digoxin	Digoxin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1240	Digoxin	Digoxin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1240	Digoxin	Digoxin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1241	Digoxin	Digoxin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1241	Digoxin	Digoxin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1241	Digoxin	Digoxin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1241	Digoxin	Digoxin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1241	Digoxin	Digoxin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0615-0518	Digoxin	Digoxin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-0547	Digoxin	Digoxin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8202	Digoxin	Digoxin	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8202	Digoxin	Digoxin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-5921	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-5921	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-5921	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-5921	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-5921	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-5922	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-5922	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-5922	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-5922	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-5922	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
0904-6886	Digoxin	Digoxin	Major Pharmaceuticals	ANDA	Current
50090-4432	Digoxin	Digoxin	A-S Medication Solutions	ANDA	Current
50090-4449	Digoxin	Digoxin	A-S Medication Solutions	ANDA	Current
53808-0165	DIGOXIN	DIGOXIN	DEPT HEALTH CENTRAL PHARMACY	ANDA	Current
53808-0237	Digoxin	DIGOXIN	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0355	Digoxin	DIGOXIN	State of Florida DOH Central Pharmacy	ANDA	Current
55154-3375	Digoxin	Digoxin	Cardinal Health	ANDA	Current
55154-5882	Digoxin	Digoxin	Cardinal Health	ANDA	Current
55154-5882	Digoxin	Digoxin	Cardinal Health	ANDA	Current
55154-5882	Digoxin	Digoxin	Cardinal Health	ANDA	Current
55154-5882	Digoxin	Digoxin	Cardinal Health 107, LLC	ANDA	Current
58118-1240	Digoxin	Digoxin	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-1240	Digoxin	Digoxin	Clinical Solutions Wholesale, LLC	ANDA	Current
60429-099	Digoxin	Digoxin	Golden State Medical Supply Inc.	ANDA	Current
60429-099	Digoxin	Digoxin	Golden State Medical Supply	ANDA	Current
60429-099	Digoxin	Digoxin	Golden State Medical Supply Inc	ANDA	Current
60429-100	Digoxin	Digoxin	Golden State Medical Supply Inc.	ANDA	Current
60429-100	Digoxin	Digoxin	Golden State Medical Supply	ANDA	Current
60429-100	Digoxin	Digoxin	Golden State Medical Supply Inc	ANDA	Current
63629-2579	Digoxin	Digoxin	Bryant Ranch Prepack	ANDA	Current
63629-2579	Digoxin	Digoxin	Bryant Ranch Prepack	ANDA	Current
63629-3870	Digoxin	Digoxin	Bryant Ranch Prepack	ANDA	Current
63629-3870	Digoxin	Digoxin	Bryant Ranch Prepack	ANDA	Current
68071-4188	Digoxin	Digoxin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4398	Digoxin	Digoxin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4469	Digoxin	Digoxin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1036	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-1036	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-1036	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-1036	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-1036	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-1036	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-1250	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-1250	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-3124	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current