Details for New Drug Application (NDA): 077094
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NDA 077094 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 077094
| Tradename: | RIBAVIRIN |
| Applicant: | Zydus Pharms Usa |
| Ingredient: | ribavirin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077094
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIBAVIRIN | ribavirin | TABLET;ORAL | 077094 | ANDA | Zydus Lifesciences Limited | 65841-046 | 65841-046-03 | 168 TABLET, FILM COATED in 1 BOTTLE (65841-046-03) |
| RIBAVIRIN | ribavirin | TABLET;ORAL | 077094 | ANDA | Zydus Lifesciences Limited | 65841-046 | 65841-046-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-046-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Dec 5, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Mar 16, 2007 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Mar 16, 2007 | TE: | RLD: | No | |||||
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