Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207366
Company: NAVINTA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIBAVIRIN RIBAVIRIN 6GM/VIAL FOR SOLUTION;INHALATION Prescription AN No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/06/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207366Orig1s000ltr.pdf

RIBAVIRIN

FOR SOLUTION;INHALATION; 6GM/VIAL
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIBAVIRIN RIBAVIRIN 6GM/VIAL FOR SOLUTION;INHALATION Prescription No AN 207366 NAVINTA LLC
VIRAZOLE RIBAVIRIN 6GM/VIAL FOR SOLUTION;INHALATION Prescription Yes AN 018859 VALEANT PHARM INTL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English