Details for New Drug Application (NDA): 215404
✉ Email this page to a colleague
NDA 215404 describes ACYCLOVIR SODIUM, which is a drug marketed by Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hikma, Hospira, Norvium Bioscience, Slate Run Pharma, Teva Parenteral, and Zydus Pharms, and is included in nineteen NDAs. It is available from nine suppliers. Additional details are available on the ACYCLOVIR SODIUM profile page.
The generic ingredient in ACYCLOVIR SODIUM is acyclovir sodium. There are fifty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
The generic ingredient in ACYCLOVIR SODIUM is acyclovir sodium. There are fifty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 215404
| Tradename: | ACYCLOVIR SODIUM |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | acyclovir sodium |
| Patents: | 0 |
Pharmacology for NDA: 215404
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 215404
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 215404 | ANDA | Fresenius Kabi USA, LLC | 65219-622 | 65219-622-10 | 10 VIAL in 1 CARTON (65219-622-10) / 10 mL in 1 VIAL (65219-622-02) |
| ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 215404 | ANDA | Fresenius Kabi USA, LLC | 65219-624 | 65219-624-20 | 10 VIAL in 1 CARTON (65219-624-20) / 20 mL in 1 VIAL (65219-624-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
| Approval Date: | Jun 25, 2024 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
