MedPath
FDA Approval

RIBAVIRIN

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

FDA Approval Summary

Company
Navinta LLC
DUNS: 130443810
Effective Date
December 2, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ribavirin(6 g in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Navinta LLC

130443810

Products1

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

RIBAVIRIN

Product Details

NDC Product Code
68475-003
Application Number
ANDA207366
Marketing Category
ANDA (C73584)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
December 2, 2022
RibavirinActive
Code: 49717AWG6KClass: ACTIBQuantity: 6 g in 1 1
© Copyright 2025. All Rights Reserved by MedPath