APPLICATION
ANDA074969
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-26
LATEST ACTION
2002-07-09
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
2002-07-09Labeling · Supplement 4AP
2002-02-01Labeling · Supplement 3AP
2000-06-09Labeling · Supplement 2AP
1999-03-22Manufacturing (CMC) · Supplement 1AP
1997-08-26OriginalAP
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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