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FDA Approval

valganciclovir hydrochloride

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 28, 2023
Labeling Type
Human Prescription Drug Label
Valganciclovir(50 mg in 1 mL)

Manufacturing Establishments1

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

MSN Pharmaceuticals Inc.

MAJOR PHARMACEUTICALS

079229051

Products1

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

valganciclovir hydrochloride

Product Details

NDC Product Code
0904-7419
Application Number
ANDA210169
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 28, 2023
FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
Code: 4P3T9QF9NZClass: ACTIRQuantity: 50 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
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