APPLICATION
ANDA075774
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-01
LATEST ACTION
2009-06-09
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
AMMONIUM LACTATEPrescription
AMMONIUM LACTATE EQ 12% BASE · CREAM · TOPICAL
Approval history
2009-06-09Labeling · Supplement 4AP
2002-12-26Labeling · Supplement 2AP
2002-12-26Manufacturing (CMC) · Supplement 1AP
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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