Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207366
Company: NAVINTA LLC
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 | BAUSCH |