Details for New Drug Application (NDA): 207366
✉ Email this page to a colleague
NDA 207366 describes RIBAVIRIN, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, Teva, Zydus Pharms Usa, Navinta Llc, Beximco Pharms Usa, Heritage Pharma Avet, and Sandoz, and is included in eleven NDAs. It is available from four suppliers. Additional details are available on the RIBAVIRIN profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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
