Details for New Drug Application (NDA): 206606
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NDA 206606 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 206606
| Tradename: | ACYCLOVIR SODIUM |
| Applicant: | Zydus Pharms |
| Ingredient: | acyclovir sodium |
| Patents: | 0 |
Pharmacology for NDA: 206606
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 206606
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 206606 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-125 | 68382-125-10 | 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68382-125-10) |
| ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 206606 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-126 | 68382-126-10 | 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68382-126-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jun 13, 2017 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Jun 13, 2017 | TE: | RLD: | No | |||||
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