Application 083217

Type: ANDA
Sponsor: ABRAXIS PHARM

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 44.

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
A083217-001	DIGOXIN	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION		Approved before 1982

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A083217-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083217-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083217-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083217-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	Bryant Ranch Prepack	e61d2108-d871-44c0-b12a-2e61fbb56967	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	NCS HealthCare of KY, LLC dba Vangard Labs	5886e233-b2da-4acb-be05-9bf40fb8e7f4	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
DIGOXIN	DIGOXIN	HF Acquisition Co LLC, DBA HealthFirst	75c99fc4-33b6-c3ce-e053-2991aa0a4d88	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: DIGOXIN generic name: DIGOXIN
Digoxin	DIGOXIN	Coupler LLC	53e5aec1-052b-454e-e063-6394a90a87f3	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Cardinal Health 107, LLC	6aba2b38-5de0-4813-9775-39d87613893d	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Henry Schein, Inc.	98d2ad5b-9ffa-4456-9a01-567636c3a4d2	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Golden State Medical Supply, Inc.	2636527a-1ecd-455f-a928-19549ac83fa1	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	9b9a4b3c-5f08-475a-a74d-0c7ebba40644	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Cardinal Health 107, LLC	51925501-ab5b-4e12-a67e-ec2b4b592e83	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	REMEDYREPACK INC.	dbc0bc24-f250-47e8-8d10-6aef551823d7	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	REMEDYREPACK INC.	9ca08b66-55eb-4155-a8bd-6fa2282adab4	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Bryant Ranch Prepack	dcf9b23b-5840-46ff-bb61-c57a02831a03	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Bryant Ranch Prepack	e23bf2a6-1c24-44c4-8135-e469900f84b2	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Major Pharmaceuticals	48cad559-c17b-4d41-a154-e664e958c1c0	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	A-S Medication Solutions	9f5f6254-2b3a-46ce-9b55-e5826caeed91	2026-02-14	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	A-S Medication Solutions	ca595f0c-5bf0-4feb-8183-47832ee8c820	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Oliva Therapeutics, LLC	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Amneal Pharmaceuticals of New York LLC	dfac7f13-28be-423d-9389-9089da29da17	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	Northwind Health Company, LLC	f9897bec-c16f-2728-e053-6394a90aecb7	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN
Digoxin	DIGOXIN	ProPharma Distribution	45b0d1e0-d1f6-28f6-e063-6394a90aaa51	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Digoxin generic name: DIGOXIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.