Application 020405

Type: NDA
Sponsor: CONCORDIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LANOXIN	DIGOXIN	TABLET;ORAL	0.0625MG	Yes	No
002	LANOXIN	DIGOXIN	TABLET;ORAL	0.125MG	Yes	No
003	LANOXIN	DIGOXIN	TABLET;ORAL	0.1875MG	Yes	No
004	LANOXIN	DIGOXIN	TABLET;ORAL	0.25MG	Yes	Yes
005	LANOXIN	DIGOXIN	TABLET;ORAL	0.375MG	No	No
006	LANOXIN	DIGOXIN	TABLET;ORAL	0.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020405-001	LANOXIN	DIGOXIN	0.0625MG	TABLET / ORAL	AB	RLD	1997-09-30
N020405-002	LANOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB	RLD	1997-09-30
N020405-003	LANOXIN	DIGOXIN	0.1875MG	TABLET / ORAL		RLD	1997-09-30
N020405-004	LANOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB	RLD, RS	1997-09-30
N020405-005	LANOXIN	DIGOXIN	0.375MG	TABLET / ORAL			1997-09-30
N020405-006	LANOXIN	DIGOXIN	0.5MG	TABLET / ORAL			1997-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020405-001	AB
N020405-002	AB
N020405-004	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 7 · 258 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
2026-09-14 22:38:34	2026-08	N020405-001	LANOXIN	0.0625MG	TABLET / ORAL	AB	RLD	1997-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020405-002	LANOXIN	0.125MG	TABLET / ORAL	AB	RLD	1997-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020405-003	LANOXIN	0.1875MG	TABLET / ORAL		RLD	1997-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020405-004	LANOXIN	0.25MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020405-005	LANOXIN	0.375MG	TABLET / ORAL			1997-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020405-006	LANOXIN	0.5MG	TABLET / ORAL			1997-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020405-001	LANOXIN	0.0625MG	TABLET / ORAL	AB	RLD	1997-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020405-002	LANOXIN	0.125MG	TABLET / ORAL	AB	RLD	1997-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020405-003	LANOXIN	0.1875MG	TABLET / ORAL		RLD	1997-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020405-004	LANOXIN	0.25MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020405-005	LANOXIN	0.375MG	TABLET / ORAL			1997-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020405-006	LANOXIN	0.5MG	TABLET / ORAL			1997-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020405-001	LANOXIN	0.0625MG	TABLET / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020405-002	LANOXIN	0.125MG	TABLET / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020405-003	LANOXIN	0.1875MG	TABLET / ORAL		RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020405-004	LANOXIN	0.25MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020405-005	LANOXIN	0.375MG	TABLET / ORAL			1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020405-006	LANOXIN	0.5MG	TABLET / ORAL			1997-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020405-001	LANOXIN	0.0625MG	TABLET / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020405-002	LANOXIN	0.125MG	TABLET / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020405-003	LANOXIN	0.1875MG	TABLET / ORAL		RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020405-004	LANOXIN	0.25MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020405-005	LANOXIN	0.375MG	TABLET / ORAL			1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020405-006	LANOXIN	0.5MG	TABLET / ORAL			1997-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020405-001	LANOXIN	0.0625MG	TABLET / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020405-002	LANOXIN	0.125MG	TABLET / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020405-003	LANOXIN	0.1875MG	TABLET / ORAL		RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020405-004	LANOXIN	0.25MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020405-005	LANOXIN	0.375MG	TABLET / ORAL			1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020405-006	LANOXIN	0.5MG	TABLET / ORAL			1997-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020405-001	LANOXIN	0.0625MG	TABLET / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020405-002	LANOXIN	0.125MG	TABLET / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020405-003	LANOXIN	0.1875MG	TABLET / ORAL		RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020405-004	LANOXIN	0.25MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020405-005	LANOXIN	0.375MG	TABLET / ORAL			1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020405-006	LANOXIN	0.5MG	TABLET / ORAL			1997-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020405-001	LANOXIN	0.0625MG	TABLET / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020405-002	LANOXIN	0.125MG	TABLET / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020405-003	LANOXIN	0.1875MG	TABLET / ORAL		RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020405-004	LANOXIN	0.25MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020405-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020405-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020405-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020405-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020405-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020405-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020405-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020405-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020405-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020405-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020405-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020405-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020405-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020405-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020405-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020405-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020405-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020405-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020405-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020405-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020405-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020405-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020405-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020405-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020405-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020405-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020405-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020405-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020405-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020405-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020405-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020405-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020405-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020405-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020405-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020405-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020405-004	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020405-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020405-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020405-004	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LANOXIN	DIGOXIN	Advanz Pharma (US) Corp.	d91e3646-4c63-4512-ab22-db39c085c4dc	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020405 application number: NDA020405 ndc (product): 59212-249 ndc (product): 59212-245 ndc (product): 59212-242 ndc (product): 59212-240
LANOXIN	DIGOXIN	Aphena Pharma Solutions - Tennessee, LLC	f6c7ca21-1c76-4838-8fb9-e1bec6001d8b	2019-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020405 application number: NDA020405 ndc (product): 71610-019

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7935	DIGOXIN	DIGOXIN	NCS HealthCare of KY, Inc dba Vangard Labs	NDA AUTHORIZED GENERIC	Current
49884-494	DIGOXIN	DIGOXIN	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
49884-514	DIGOXIN	DIGOXIN	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
53808-1006	DIGOXIN	DIGOXIN	State of Florida DOH Central Pharmacy	NDA AUTHORIZED GENERIC	Current
55154-6726	LANOXIN	digoxin	Cardinal Health	NDA	Current
59212-240	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-240	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-240	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-240	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-240	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-240	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-242	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-242	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-242	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-242	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-242	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-242	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-245	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-249	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-249	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-249	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-249	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-249	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
59212-249	LANOXIN	digoxin	Concordia Pharmaceuticals Inc.	NDA	Current
65084-455	LANOXIN	digoxin	Mckesson Rxpak Inc	NDA	Current
66267-078	DIGOXIN	DIGOXIN	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
66267-078	DIGOXIN	DIGOXIN	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
66267-443	DIGOXIN	DIGOXIN	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
66267-443	DIGOXIN	DIGOXIN	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68071-3011	DIGOXIN	DIGOXIN	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68071-3011	DIGOXIN	DIGOXIN	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
70518-0298	DIGOXIN	DIGOXIN	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-0338	DIGOXIN	DIGOXIN	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-0848	DIGOXIN	DIGOXIN	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-0848	DIGOXIN	DIGOXIN	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-0913	DIGOXIN	DIGOXIN	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-0913	DIGOXIN	DIGOXIN	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
71610-019	LANOXIN	digoxin	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-019	LANOXIN	digoxin	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78312	SUPPL	2024-04-30
78304	SUPPL	2024-04-30
57815	SUPPL	2019-02-27
57799	SUPPL	2019-02-25
55337	SUPPL	2018-08-28
55301	SUPPL	2018-08-24
46136	SUPPL	2016-12-13
46020	SUPPL	2016-12-05
12542	SUPPL	2015-07-30
24916	SUPPL	2015-07-29
24915	SUPPL	2013-10-21
12541	SUPPL	2013-10-18
2485	SUPPL	2012-08-16
34607	SUPPL	2012-08-15
2486	SUPPL	2011-11-16
34608	SUPPL	2011-11-14
20635	ORIG	2010-03-03
2484	SUPPL	2010-02-17
34606	SUPPL	2010-02-16