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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 083391


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NDA 083391 describes DIGOXIN, which is a drug marketed by Amici, 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-six 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. Twenty-nine 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
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:RXDosage:INJECTABLE;INJECTIONStrength0.25MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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