Details for New Drug Application (NDA): 090658
✉ Email this page to a colleague
NDA 090658 describes GANCICLOVIR SODIUM, which is a drug marketed by Am Regent, Custopharm Inc, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience Speclts, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the GANCICLOVIR SODIUM profile page.
The generic ingredient in GANCICLOVIR SODIUM 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.
The generic ingredient in GANCICLOVIR SODIUM 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 090658
| Tradename: | GANCICLOVIR SODIUM |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | ganciclovir sodium |
| Patents: | 0 |
Pharmacology for NDA: 090658
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 090658
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 090658 | ANDA | Fresenius Kabi USA, LLC | 63323-315 | 63323-315-94 | 25 VIAL in 1 TRAY (63323-315-94) / 10 mL in 1 VIAL (63323-315-41) |
| GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 090658 | ANDA | Fresenius Kabi USA, LLC | 63323-315 | 63323-315-10 | 25 VIAL in 1 TRAY (63323-315-10) / 10 mL in 1 VIAL (63323-315-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jun 21, 2010 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
