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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 215209


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NDA 215209 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 215209
Tradename:DIGOXIN
Applicant:Amici
Ingredient:digoxin
Patents:0
Pharmacology for NDA: 215209
Medical Subject Heading (MeSH) Categories for 215209
Suppliers and Packaging for NDA: 215209
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIGOXIN digoxin ELIXIR;ORAL 215209 ANDA Amici Pharmaceuticals, LLC 69292-605 69292-605-60 1 BOTTLE in 1 CARTON (69292-605-60) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:ELIXIR;ORALStrength0.05MG/ML
Approval Date:Mar 11, 2022TE:AARLD:No

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