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 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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A040282-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	1999-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040282-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	1999-12-23	`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	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…`
2022-03-09 01:35 UTC	2022-03	A040282-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040282-002	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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	Bryant Ranch Prepack	e61d2108-d871-44c0-b12a-2e61fbb56967	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	NCS HealthCare of KY, LLC dba Vangard Labs	5886e233-b2da-4acb-be05-9bf40fb8e7f4	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
DIGOXIN	DIGOXIN	HF Acquisition Co LLC, DBA HealthFirst	75c99fc4-33b6-c3ce-e053-2991aa0a4d88	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: DIGOXIN generic name: DIGOXIN
Digoxin	DIGOXIN	Coupler LLC	53e5aec1-052b-454e-e063-6394a90a87f3	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Cardinal Health 107, LLC	6aba2b38-5de0-4813-9775-39d87613893d	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Bryant Ranch Prepack	5fb1bc4e-5806-4c50-aab0-91e445d87933	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Henry Schein, Inc.	98d2ad5b-9ffa-4456-9a01-567636c3a4d2	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Golden State Medical Supply, Inc.	2636527a-1ecd-455f-a928-19549ac83fa1	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	9b9a4b3c-5f08-475a-a74d-0c7ebba40644	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Cardinal Health 107, LLC	51925501-ab5b-4e12-a67e-ec2b4b592e83	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	REMEDYREPACK INC.	dbc0bc24-f250-47e8-8d10-6aef551823d7	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	REMEDYREPACK INC.	9ca08b66-55eb-4155-a8bd-6fa2282adab4	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Bryant Ranch Prepack	dcf9b23b-5840-46ff-bb61-c57a02831a03	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Bryant Ranch Prepack	e23bf2a6-1c24-44c4-8135-e469900f84b2	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Major Pharmaceuticals	48cad559-c17b-4d41-a154-e664e958c1c0	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	A-S Medication Solutions	9f5f6254-2b3a-46ce-9b55-e5826caeed91	2026-02-14	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	A-S Medication Solutions	ca595f0c-5bf0-4feb-8183-47832ee8c820	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Oliva Therapeutics, LLC	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Amneal Pharmaceuticals of New York LLC	dfac7f13-28be-423d-9389-9089da29da17	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Northwind Health Company, LLC	f9897bec-c16f-2728-e053-6394a90aecb7	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN

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