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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
RedPharm Drug, Inc.
DUNS: 828374897
Effective Date
January 13, 2021
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.

RedPharm Drug, Inc.

RedPharm Drug, Inc.

828374897

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
67296-0691
Application Number
NDA018487
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
January 13, 2021
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 20 mg in 1 1
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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