Application 214982

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIGOXIN	DIGOXIN	TABLET;ORAL	0.0625MG	No	No
002	DIGOXIN	DIGOXIN	TABLET;ORAL	0.125MG	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214982-001	DIGOXIN	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08
A214982-002	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08
A214982-003	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214982-001	AB
A214982-002	AB
A214982-003	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 · 99 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	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A214982-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214982-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214982-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214982-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214982-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214982-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214982-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214982-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214982-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214982-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214982-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214982-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214982-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214982-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214982-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214982-001	AB	1	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214982-001	CGT	2022-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214982-001	CGT	2022-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214982-001	CGT	2022-08-16	`4b0b4de00fa7…`
2023-01-26 05:58 UTC	2023-01	A214982-001	CGT	2022-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214982-001	CGT	2022-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214982-001	CGT	2022-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214982-001	CGT	2022-08-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214982-001	CGT	2022-08-16	`cb3db0bc1861…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	Coupler LLC	53e5aec1-052b-454e-e063-6394a90a87f3	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	REMEDYREPACK INC.	dbc0bc24-f250-47e8-8d10-6aef551823d7	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	REMEDYREPACK INC.	9ca08b66-55eb-4155-a8bd-6fa2282adab4	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	A-S Medication Solutions	9f5f6254-2b3a-46ce-9b55-e5826caeed91	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	A-S Medication Solutions	ca595f0c-5bf0-4feb-8183-47832ee8c820	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	AvPAK	1cfd4e43-56f0-d182-e063-6394a90ad231	2024-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	Aurobindo Pharma Limited	2bcd56ee-4497-4b8d-84db-a1470c77827b	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982 ndc (product): 59651-437 ndc (product): 59651-436 ndc (product): 59651-438

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-436	Digoxin	Digoxin	Aurobindo Pharma Limited	ANDA	Current
59651-437	Digoxin	Digoxin	Aurobindo Pharma Limited	ANDA	Current
59651-438	Digoxin	Digoxin	Aurobindo Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71710	ORIG	2022-08-04