APPLICATION
ANDA074623
TYPE
ANDA
ORIGINAL APPROVAL
1996-07-30
LATEST ACTION
2020-03-24
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LACTULOSEPrescription
LACTULOSE 10GM/15ML · SOLUTION · ORAL
Approval history
2020-03-24Labeling · Supplement 12 · standardAP
2020-03-24Labeling · Supplement 10 · standardAP
2020-03-24Labeling · Supplement 11 · standardAP
1996-07-30OriginalAP
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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