APPLICATION
ANDA086835
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-14
LATEST ACTION
1986-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
POLARAMINE · ReferenceDiscontinued
DEXCHLORPHENIRAMINE MALEATE 2MG · TABLET · ORAL
Approval history
1986-07-24Manufacturing (CMC) · Supplement 5AP
1985-07-25Manufacturing (CMC) · Supplement 4AP
1984-05-18Manufacturing (CMC) · Supplement 3AP
1983-03-11Manufacturing (CMC) · Supplement 2AP
1981-07-14OriginalAP
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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