APPLICATION
ANDA074720
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-22
LATEST ACTION
2004-09-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ACYCLOVIR SODIUMDiscontinued
ACYCLOVIR SODIUM EQ 25MG BASE/ML · INJECTABLE · INJECTION
Approval history
2004-09-30Labeling · Supplement 19AP
2003-10-10Labeling · Supplement 17AP
2000-11-27Labeling · Supplement 14AP
2000-09-29Manufacturing (CMC) · Supplement 9AP
2000-08-21Labeling · Supplement 10AP
2000-08-08Manufacturing (CMC) · Supplement 8AP
2000-04-28Manufacturing (CMC) · Supplement 7AP
1999-06-18Manufacturing (CMC) · Supplement 6AP
1998-09-25Manufacturing (CMC) · Supplement 5AP
1998-09-25Manufacturing (CMC) · Supplement 3AP
1998-06-22Manufacturing (CMC) · Supplement 4AP
1997-06-27Labeling · Supplement 1AP
1997-04-22OriginalAP
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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