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FDA Approval

Furosemide

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

FDA Approval Summary

Company
Effective Date
March 1, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Furosemide(10 mg in 1 mL)

Manufacturing Establishments1

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

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products1

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

Furosemide

Product Details

NDC Product Code
54868-2299
Application Number
ANDA018579
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 1, 2012
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
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