Application 215307

Type: ANDA
Sponsor: NOVITIUM PHARMA

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
003	DIGOXIN	DIGOXIN	TABLET;ORAL	0.0625MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215307-001	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22
A215307-002	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22
A215307-003	DIGOXIN	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215307-001	AB
A215307-002	AB
A215307-003	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 · 93 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
2026-02-19 14:30 UTC	2026-02	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215307-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2021-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215307-003	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215307-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2021-11-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 93 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215307-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215307-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215307-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215307-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215307-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215307-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215307-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215307-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215307-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215307-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215307-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215307-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215307-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215307-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215307-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215307-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215307-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215307-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215307-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215307-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215307-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215307-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215307-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215307-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215307-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215307-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215307-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215307-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215307-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215307-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215307-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215307-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215307-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215307-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215307-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215307-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215307-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215307-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215307-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215307-001	AB	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	Northwind Health Company, LLC	f9897bec-c16f-2728-e053-6394a90aecb7	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215307 application number: ANDA215307
Digoxin	DIGOXIN	Marlex Pharmaceuticals, Inc.	e104c3c5-e4b8-7dbd-e053-2995a90ae339	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215307 application number: ANDA215307 ndc (product): 10135-747 ndc (product): 10135-748
Digoxin	DIGOXIN	American Health Packaging	5500ee2a-077d-486c-b56d-36e0c5e5c31d	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215307 application number: ANDA215307
Digoxin	DIGOXIN	ANI Pharmaceuticals, Inc.	dba3b3f7-3ff2-4996-8653-b0e54a398bf9	2024-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215307 application number: ANDA215307 ndc (product): 70954-201 ndc (product): 70954-200 ndc (product): 70954-202

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-747	Digoxin	Digoxin	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-748	Digoxin	Digoxin	Marlex Pharmaceuticals, Inc.	ANDA	Current
70954-200	Digoxin	Digoxin	Novitium Pharma LLC	ANDA	Current
70954-201	Digoxin	Digoxin	Novitium Pharma LLC	ANDA	Current
70954-201	Digoxin	Digoxin	Novitium Pharma LLC	ANDA	Current
70954-201	Digoxin	Digoxin	Novitium Pharma LLC	ANDA	Current
70954-202	Digoxin	Digoxin	Novitium Pharma LLC	ANDA	Current
70954-202	Digoxin	Digoxin	Novitium Pharma LLC	ANDA	Current
70954-202	Digoxin	Digoxin	Novitium Pharma LLC	ANDA	Current