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FDA Approval

Vinorelbine

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

FDA Approval Summary

Company
Sagent Pharmaceuticals
DUNS: 796852890
Effective Date
April 3, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vinorelbine(10 mg in 1 mL)

Products1

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

Vinorelbine

Product Details

NDC Product Code
25021-204
Application Number
ANDA091106
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
April 3, 2020
waterInactive
Code: 059QF0KO0RClass: IACT
Code: 253GQW851QClass: ACTIMQuantity: 10 mg in 1 mL
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