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FDA ANDA · ANDA080961

CHLORPHENIRAMINE MALEATE

Sponsor: AUROLIFE PHARMA LLC

APPLICATION
ANDA080961
TYPE
ANDA
ORIGINAL APPROVAL
1972-12-20
LATEST ACTION
1996-03-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CHLORPHENIRAMINE MALEATEDiscontinued
CHLORPHENIRAMINE MALEATE 4MG · TABLET · ORAL

Approval history

1996-03-28Manufacturing (CMC) · Supplement 79AP
1995-01-31Manufacturing (CMC) · Supplement 78AP
1989-09-27Manufacturing (CMC) · Supplement 72AP
1989-02-21Manufacturing (CMC) · Supplement 77AP
1988-11-01Manufacturing (CMC) · Supplement 70AP
1988-04-01Manufacturing (CMC) · Supplement 76AP
1988-04-01Manufacturing (CMC) · Supplement 74AP
1988-04-01Manufacturing (CMC) · Supplement 75AP
1987-07-17Manufacturing (CMC) · Supplement 73AP
1984-08-23Manufacturing (CMC) · Supplement 68AP
1984-08-23Manufacturing (CMC) · Supplement 67AP
1983-12-14Manufacturing (CMC) · Supplement 66AP
1983-07-12Manufacturing (CMC) · Supplement 64AP
1983-02-22Manufacturing (CMC) · Supplement 62AP
1982-07-06Manufacturing (CMC) · Supplement 60AP
1972-12-20OriginalAP
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