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FDA Approval

Digoxin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 16, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Digoxin(0.25 mg in 30 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Northwind Pharmaceuticals

036986393

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Northwind Pharmaceuticals

Northwind Pharmaceuticals

Northwind Pharmaceuticals

036986393

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Digoxin

Product Details

NDC Product Code
51655-000
Application Number
ANDA076268
Marketing Category
ANDA (C73584)
Route of Administration
oral
Effective Date
May 20, 2014
DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 0.25 mg in 30 1
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