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FDA ANDA · ANDA074913

ACYCLOVIR SODIUM

Sponsor: EUROHLTH INTL SARL

APPLICATION
ANDA074913
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-15
LATEST ACTION
2000-07-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ACYCLOVIR SODIUMDiscontinued
ACYCLOVIR SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
ACYCLOVIR SODIUMDiscontinued
ACYCLOVIR SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2000-07-17Labeling · Supplement 1AP
1997-10-15OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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