APPLICATION
ANDA073580
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-04
LATEST ACTION
2015-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
EMVERMPrescription
MEBENDAZOLE 100MG · TABLET, CHEWABLE · ORAL
Approval history
2015-07-21Labeling · Supplement 25 · standardAP
2002-11-20Manufacturing (CMC) · Supplement 13AP
2002-11-20Manufacturing (CMC) · Supplement 14AP
2002-01-23Manufacturing (CMC) · Supplement 9AP
2001-10-31Manufacturing (CMC) · Supplement 12AP
2001-10-31Manufacturing (CMC) · Supplement 10AP
2001-10-31Manufacturing (CMC) · Supplement 11AP
2001-02-26Manufacturing (CMC) · Supplement 8AP
1999-03-23Manufacturing (CMC) · Supplement 7AP
1999-01-25Labeling · Supplement 6AP
1998-06-11Manufacturing (CMC) · Supplement 5AP
1998-02-03Manufacturing (CMC) · Supplement 3AP
1998-02-03Manufacturing (CMC) · Supplement 4AP
1996-05-31Manufacturing (CMC) · Supplement 2AP
1995-05-26Labeling · Supplement 1AP
1995-01-04OriginalAP
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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