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FDA Approval

Furosemide

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

FDA Approval Summary

Effective Date
May 30, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Furosemide(20 mg in 1 1)

Manufacturing Establishments1

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

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

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
71610-284
Application Number
NDA018487
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
May 30, 2019
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 20 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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