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FDA ANDA · ANDA080700

CHLORPHENIRAMINE MALEATE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA080700
TYPE
ANDA
ORIGINAL APPROVAL
1972-08-24
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CHLORPHENIRAMINE MALEATEDiscontinued
CHLORPHENIRAMINE MALEATE 4MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 50AP
1994-12-23Manufacturing (CMC) · Supplement 49AP
1994-10-11Manufacturing (CMC) · Supplement 48AP
1992-04-03Manufacturing (CMC) · Supplement 47AP
1992-04-03Manufacturing (CMC) · Supplement 45AP
1987-04-09Manufacturing (CMC) · Supplement 44AP
1972-08-24OriginalAP
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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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