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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 083391

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NDA 083391 describes DIGOXIN, which is a drug marketed by Amici Pharma, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Novitium Pharma, Rising, Stevens J, and Sun Pharm Inds Inc, and is included in seventeen NDAs. It is available from twenty-seven suppliers. Additional details are available on the DIGOXIN profile page.

The generic ingredient in DIGOXIN is digoxin. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for 083391

Tradename:	DIGOXIN
Applicant:	Hikma
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 083391

Medical Subject Heading (MeSH) Categories for 083391

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 083391

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	INJECTABLE;INJECTION	083391	ANDA	Henry Schein, Inc.	0404-9850	0404-9850-02	1 AMPULE in 1 BAG (0404-9850-02) / 2 mL in 1 AMPULE
DIGOXIN	digoxin	INJECTABLE;INJECTION	083391	ANDA	Hikma Pharmaceuticals USA Inc.	0641-1410	0641-1410-35	25 AMPULE in 1 CARTON (0641-1410-35) / 2 mL in 1 AMPULE (0641-1410-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.25MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	No

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