Details for New Drug Application (NDA): 020460
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The generic ingredient in CYTOVENE is ganciclovir sodium. There are twenty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.
Summary for 020460
| Tradename: | CYTOVENE |
| Applicant: | Roche Palo |
| Ingredient: | ganciclovir |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020460
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 22, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 12, 1997 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020460
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche Palo | CYTOVENE | ganciclovir | CAPSULE;ORAL | 020460-002 | Dec 12, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Roche Palo | CYTOVENE | ganciclovir | CAPSULE;ORAL | 020460-001 | Dec 22, 1994 | ⤷ Get Started Free | ⤷ Get Started Free |
| Roche Palo | CYTOVENE | ganciclovir | CAPSULE;ORAL | 020460-002 | Dec 12, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Roche Palo | CYTOVENE | ganciclovir | CAPSULE;ORAL | 020460-002 | Dec 12, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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