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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 206535


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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, Mylan Labs Ltd, Teva Parenteral, and Zydus Pharms, and is included in eighteen 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 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 206535
Tradename:ACYCLOVIR SODIUM
Applicant:Zydus Pharms
Ingredient:acyclovir sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206535
Mechanism of ActionDNA 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:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Aug 31, 2018TE:APRLD:No

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