Application 040282

Type: ANDA
Sponsor: MYLAN PHARMS INC

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 43.

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
A040282-001	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB		1999-12-23
A040282-002	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB		1999-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040282-001	AB
A040282-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040282-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040282-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040282-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040282-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040282-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040282-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040282-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040282-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040282-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040282-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040282-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040282-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040282-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040282-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040282-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040282-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040282-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040282-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040282-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040282-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040282-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040282-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040282-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040282-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040282-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040282-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040282-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040282-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040282-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040282-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040282-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040282-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040282-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040282-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040282-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040282-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040282-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040282-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040282-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040282-002	AB	1	`74a2ff9319b5…`

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	Atlantic Biologicals Corps	dcf907d9-0f0e-4ecc-a555-7e6dcc08c166	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Sandoz Inc	58f45aba-ff6f-43cc-bb88-be40a9f7beda	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Amici Pharma, Inc	eda7193a-e139-41d5-a11b-dc6241645995	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
LANOXIN	DIGOXIN	Covis Pharma US, Inc	9ec84cac-6ecc-43dc-8006-6ccc029e2707	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: DIGOXIN
Digoxin	DIGOXIN	Marlex Pharmaceuticals, Inc.	e104c3c5-e4b8-7dbd-e053-2995a90ae339	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Proficient Rx LP	42d079a7-def1-4220-b71f-db2651966ffe	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	VistaPharm, LLC	ce62a741-a981-4880-8ce3-93269606a730	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	3933b07f-5857-4a80-b502-e3214bdf9330	2025-06-07	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	1b7e5c6e-e052-41b0-a4ce-05dfe62faaaf	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	American Health Packaging	5500ee2a-077d-486c-b56d-36e0c5e5c31d	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Medical Purchasing Solutions, LLC	28f2c2cd-e58c-aea2-e063-6394a90a73e7	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
LANOXIN	DIGOXIN	Advanz Pharma (US) Corp.	d91e3646-4c63-4512-ab22-db39c085c4dc	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: DIGOXIN
Digoxin	DIGOXIN	Bryant Ranch Prepack	03612934-62f4-4002-85af-6c66cd172acb	2024-09-04	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Bryant Ranch Prepack	4b893a4a-31e6-4a7a-b16c-02b1e578335b	2024-09-04	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	AvPAK	1cfd4e43-56f0-d182-e063-6394a90ad231	2024-07-11	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	41c16cff-b03e-405e-a617-d6f45d3ce2bd	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Aurobindo Pharma Limited	2bcd56ee-4497-4b8d-84db-a1470c77827b	2024-05-15	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	ANI Pharmaceuticals, Inc.	dba3b3f7-3ff2-4996-8653-b0e54a398bf9	2024-05-10	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	A-S Medication Solutions	3d6afb9e-0c6c-40e1-ae26-6e544564ba44	2024-01-15	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Amneal Pharmaceuticals NY LLC	f3d29508-e7cc-47ff-845d-b5375ee30407	2023-12-29	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6155	DIGITEK	digoxin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6155	DIGITEK	digoxin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6156	DIGITEK	digoxin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6156	DIGITEK	digoxin	Mylan Pharmaceuticals Inc.	ANDA	Current
42292-002	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current
42292-002	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current
42292-002	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current
42292-002	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current
42292-002	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current
42292-003	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current
42292-003	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current
42292-003	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current
42292-003	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current
42292-003	DIGITEK	digoxin	Mylan Institutional Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7603	SUPPL	2014-09-04
29912	ORIG	1999-12-23
22116	ORIG	1999-12-23