Application 076363

Type: ANDA
Sponsor: SUN PHARM INDS 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
A076363-001	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL			2003-01-31
A076363-002	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL			2003-01-31

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	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL		2003-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL		2003-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A076363-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076363-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076363-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076363-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076363-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076363-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076363-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076363-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076363-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076363-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076363-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076363-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076363-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076363-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076363-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076363-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076363-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076363-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076363-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076363-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076363-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076363-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076363-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076363-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076363-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076363-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076363-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076363-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076363-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076363-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076363-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076363-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076363-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076363-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076363-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076363-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076363-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076363-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076363-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076363-002	AB	1	`782e0a99824c…`

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	Bryant Ranch Prepack	5fb1bc4e-5806-4c50-aab0-91e445d87933	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076363 application number: ANDA076363 ndc (product): 71335-9610
Digoxin	DIGOXIN	A-S Medication Solutions	3d6afb9e-0c6c-40e1-ae26-6e544564ba44	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076363 application number: ANDA076363 ndc (product): 50090-5642
Digoxin	DIGOXIN	A-S Medication Solutions	aea39b37-951e-49e8-9756-c763c0e7c7cd	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076363 application number: ANDA076363 ndc (product): 50090-5862
Digoxin	DIGOXIN	A-S Medication Solutions	0a88434e-4a1b-4ade-a51e-38145e22a232	2023-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076363 application number: ANDA076363

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-590	Digoxin	Digoxin	Northstar Rx LLC	ANDA	Current
16714-590	Digoxin	Digoxin	Northstar Rx LLC	ANDA	Current
16714-590	Digoxin	Digoxin	Northstar Rx LLC	ANDA	Current
16714-590	Digoxin	Digoxin	Northstar Rx LLC	ANDA	Current
16714-591	Digoxin	Digoxin	Northstar Rx LLC	ANDA	Current
16714-591	Digoxin	Digoxin	Northstar Rx LLC	ANDA	Current
16714-591	Digoxin	Digoxin	Northstar Rx LLC	ANDA	Current
16714-591	Digoxin	Digoxin	Northstar Rx LLC	ANDA	Current
50090-5642	Digoxin	Digoxin	A-S Medication Solutions	ANDA	Current
50090-5642	Digoxin	Digoxin	A-S Medication Solutions	ANDA	Current
50090-5862	Digoxin	Digoxin	A-S Medication Solutions	ANDA	Current
51407-125	Digoxin	Digoxin	Golden State Medical Supply	ANDA	Current
51407-125	Digoxin	Digoxin	Golden State Medical Supply	ANDA	Current
51407-125	Digoxin	Digoxin	Golden State Medical Supply	ANDA	Current
51407-126	Digoxin	Digoxin	Golden State Medical Supply	ANDA	Current
57664-437	Digoxin	Digoxin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-437	Digoxin	Digoxin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-437	Digoxin	Digoxin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-437	Digoxin	Digoxin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-441	Digoxin	Digoxin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-441	Digoxin	Digoxin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-441	Digoxin	Digoxin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-441	Digoxin	Digoxin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
60687-540	Digoxin	Digoxin	American Health Packaging	ANDA	Current
60687-540	Digoxin	Digoxin	American Health Packaging	ANDA	Current
60687-551	Digoxin	Digoxin	American Health Packaging	ANDA	Current
60687-551	Digoxin	Digoxin	American Health Packaging	ANDA	Current
70518-2959	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-2959	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
70518-3421	Digoxin	Digoxin	REMEDYREPACK INC.	ANDA	Current
71335-9610	Digoxin	Digoxin	Bryant Ranch Prepack	ANDA	Current