APPLICATION
ANDA088251
TYPE
ANDA
ORIGINAL APPROVAL
1984-03-23
LATEST ACTION
2004-04-20
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
DEXCHLORPHENIRAMINE MALEATE · ReferenceDiscontinued
DEXCHLORPHENIRAMINE MALEATE 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
Approval history
2004-04-20Labeling · Supplement 15AP
1994-04-12Labeling · Supplement 14AP
1993-08-04Labeling · Supplement 13AP
1991-09-18Labeling · Supplement 12AP
1991-04-10Labeling · Supplement 11AP
1989-10-24Labeling · Supplement 10AP
1989-04-05Manufacturing (CMC) · Supplement 9AP
1988-08-22Manufacturing (CMC) · Supplement 8AP
1987-04-07Manufacturing (CMC) · Supplement 4AP
1987-04-07Manufacturing (CMC) · Supplement 5AP
1986-04-22Manufacturing (CMC) · Supplement 3AP
1985-01-08Manufacturing (CMC) · Supplement 2AP
1984-03-23OriginalAP
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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