Details for New Drug Application (NDA): 206535
NDA 206535 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 206535
| Tradename: | ACYCLOVIR SODIUM |
| Applicant: | Zydus Pharms |
| Ingredient: | acyclovir sodium |
| Patents: | 0 |
Pharmacology for NDA: 206535
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 206535
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 206535 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-048 | 68382-048-10 | 10 VIAL, SINGLE-USE in 1 CARTON (68382-048-10) / 10 mL in 1 VIAL, SINGLE-USE (68382-048-01) |
| ACYCLOVIR SODIUM | acyclovir sodium | INJECTABLE;INJECTION | 206535 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-049 | 68382-049-10 | 10 VIAL, SINGLE-USE in 1 CARTON (68382-049-10) / 20 mL in 1 VIAL, SINGLE-USE (68382-049-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
| Approval Date: | Aug 31, 2018 | TE: | AP | RLD: | No | ||||
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