Application 018859
- Type
- NDA
- Sponsor
- VALEANT PHARM INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VIRAZOLE | RIBAVIRIN | FOR SOLUTION;INHALATION | 6GM/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0187-0007 | Virazole | Ribavirin | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-0007 | Virazole | Ribavirin | Bausch Health US, LLC | NDA | Current |
| 0187-0007 | Virazole | Ribavirin | Bausch Health US, LLC | NDA | Current |
| 42494-423 | Ribavirin | Ribavirin | Cameron Pharmaceuticals | NDA | Current |
| 63629-2149 | Ribavirin | Ribavirin | Bryant Ranch Prepack | NDA | Current |
| 63629-2149 | Ribavirin | Ribavirin | Bryant Ranch Prepack | NDA | Current |
| 63629-2149 | Ribavirin | Ribavirin | Bryant Ranch Prepack | NDA | Current |
| 68682-019 | Ribavirin | Ribavirin | Oceanside Pharmaceuticals | NDA | Current |
| 68682-019 | Ribavirin | Ribavirin | Oceanside Pharmaceuticals | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57622 | ORIG | 2019-02-15 |