Details for New Drug Application (NDA): 205771
NDA 205771 describes ACYCLOVIR SODIUM, which is a drug marketed by Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hainan Poly, Hikma, Hospira, Pharmobedient, Teva Parenteral, and Zydus Pharms, and is included in nineteen NDAs. It is available from eight suppliers. Additional details are available on the ACYCLOVIR SODIUM profile page.
The generic ingredient in ACYCLOVIR SODIUM is acyclovir sodium. There is one drug master file entry for this compound. Eight 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 205771
| Tradename: | ACYCLOVIR SODIUM |
| Applicant: | Hikma |
| Ingredient: | acyclovir sodium |
| Patents: | 0 |
Pharmacology for NDA: 205771
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 205771
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 205771 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9657 | 0143-9657-10 | 10 VIAL, SINGLE-DOSE in 1 BOX (0143-9657-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9657-01) |
| ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 205771 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9658 | 0143-9658-10 | 10 VIAL, SINGLE-DOSE in 1 BOX (0143-9658-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9658-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Feb 29, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Feb 29, 2016 | TE: | RLD: | No | |||||
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