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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
Major Pharmaceuticals
DUNS: 191427277
Effective Date
December 30, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Furosemide(40 mg in 1 1)

Products2

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
0904-7178
Application Number
ANDA076796
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 30, 2021
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 40 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

Furosemide

Product Details

NDC Product Code
0904-7177
Application Number
ANDA076796
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 30, 2021
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 20 mg in 1 1
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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