Details for New Drug Application (NDA): 074930
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The generic ingredient in ACYCLOVIR SODIUM is acyclovir sodium. There are fifty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 074930
Tradename: | ACYCLOVIR SODIUM |
Applicant: | Fresenius Kabi Usa |
Ingredient: | acyclovir sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074930
Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 074930
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 074930 | ANDA | Fresenius Kabi USA, LLC | 63323-325 | 63323-325-10 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-325-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-325-03) |
ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 074930 | ANDA | Fresenius Kabi USA, LLC | 63323-325 | 63323-325-20 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-325-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-325-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
Approval Date: | May 13, 1998 | TE: | AP | RLD: | No |
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