Details for New Drug Application (NDA): 207366
✉ Email this page to a colleague
The generic ingredient in RIBAVIRIN is ribavirin. There are fifteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
Summary for 207366
Tradename: | RIBAVIRIN |
Applicant: | Navinta Llc |
Ingredient: | ribavirin |
Patents: | 0 |
Suppliers and Packaging for NDA: 207366
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RIBAVIRIN | ribavirin | FOR SOLUTION;INHALATION | 207366 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-395 | 68382-395-04 | 4 VIAL in 1 CARTON (68382-395-04) / 1 POWDER, FOR SOLUTION in 1 VIAL |
RIBAVIRIN | ribavirin | FOR SOLUTION;INHALATION | 207366 | ANDA | Navinta LLC | 68475-003 | 68475-003-04 | 4 VIAL in 1 CARTON (68475-003-04) / 1 POWDER, FOR SOLUTION in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;INHALATION | Strength | 6GM/VIAL | ||||
Approval Date: | Oct 6, 2016 | TE: | AN | RLD: | No |
Complete Access Available with Subscription