Application 083391

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIGOXIN	DIGOXIN	INJECTABLE;INJECTION	0.25MG/ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083391-001	DIGOXIN	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A083391-001	AP

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A083391-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083391-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083391-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083391-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083391-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083391-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083391-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083391-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083391-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083391-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083391-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083391-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083391-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083391-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083391-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083391-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083391-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083391-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083391-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083391-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083391-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083391-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083391-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083391-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083391-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083391-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083391-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083391-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083391-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083391-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083391-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083391-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083391-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083391-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083391-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083391-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083391-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083391-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083391-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083391-001	AP	1	`f41ea6bd6efb…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIGOXIN	DIGOXIN	HF Acquisition Co LLC, DBA HealthFirst	75c99fc4-33b6-c3ce-e053-2991aa0a4d88	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391 ndc (product): 51662-1217
Digoxin	DIGOXIN	Cardinal Health 107, LLC	6aba2b38-5de0-4813-9775-39d87613893d	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391 ndc (product): 55154-5106
Digoxin	DIGOXIN	Henry Schein, Inc.	98d2ad5b-9ffa-4456-9a01-567636c3a4d2	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391 ndc (product): 0404-9850
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	9b9a4b3c-5f08-475a-a74d-0c7ebba40644	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391 ndc (product): 0641-6184
Digoxin	DIGOXIN	ProPharma Distribution	45b0d1e0-d1f6-28f6-e063-6394a90aaa51	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	3933b07f-5857-4a80-b502-e3214bdf9330	2025-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391 ndc (product): 0641-1410

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9850	Digoxin	Digoxin	Henry Schein, Inc.	ANDA	Current
0404-9850	Digoxin	Digoxin	Henry Schein, Inc.	ANDA	Current
0404-9850	Digoxin	Digoxin	Henry Schein, Inc.	ANDA	Current
0641-1410	Digoxin	Digoxin	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-1410	Digoxin	Digoxin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6184	Digoxin	Digoxin	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6184	Digoxin	Digoxin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
51662-1217	DIGOXIN	DIGOXIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1217	DIGOXIN	DIGOXIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1217	DIGOXIN	DIGOXIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1217	DIGOXIN	DIGOXIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1217	DIGOXIN	DIGOXIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-410	Digoxin	Digoxin	General Injectables and Vaccines, Inc	ANDA	Current
52584-410	Digoxin	Digoxin	General Injectables and Vaccines, Inc	ANDA	Current
52584-410	Digoxin	Digoxin	General Injectables and Vaccines, Inc	ANDA	Current
52584-410	Digoxin	Digoxin	General Injectables and Vaccines, Inc	ANDA	Current
55154-5106	Digoxin	Digoxin	Cardinal Health 107, LLC	ANDA	Current
55154-5106	Digoxin	Digoxin	Cardinal Health	ANDA	Current