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Last Updated: March 2, 2021

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Details for New Drug Application (NDA): 074969

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NDA 074969 describes ACYCLOVIR SODIUM, which is a drug marketed by Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Eurohlth Intl Sarl, Exela Pharma, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Teva Parenteral, and Zydus Pharms, and is included in seventeen NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 074969
Applicant:Teva Parenteral
Ingredient:acyclovir sodium
Formulation / Manufacturing:see details

Profile for product number 001

Approval Date:Aug 26, 1997TE:RLD:No

Profile for product number 002

Approval Date:Aug 26, 1997TE:RLD:No

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