APPLICATION
ANDA074603
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-31
LATEST ACTION
2001-11-26
ROUTE
ORAL, RECTAL, ORAL, RECTAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GENERLACPrescription
LACTULOSE 10GM/15ML · SOLUTION · ORAL, RECTAL
Approval history
2001-11-26Labeling · Supplement 5AP
2001-04-05Labeling · Supplement 4AP
2000-04-14Manufacturing (CMC) · Supplement 1AP
2000-04-14Manufacturing (CMC) · Supplement 2AP
1999-07-15Labeling · Supplement 3AP
1996-10-31OriginalAP
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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