APPLICATION
ANDA083215
TYPE
ANDA
ORIGINAL APPROVAL
1975-12-19
LATEST ACTION
1982-09-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BROMPHENIRAMINE MALEATEDiscontinued
BROMPHENIRAMINE MALEATE 4MG · TABLET · ORAL
Approval history
1982-09-30Manufacturing (CMC) · Supplement 29AP
1982-07-08Manufacturing (CMC) · Supplement 28AP
1982-07-01Manufacturing (CMC) · Supplement 27AP
1982-07-01Manufacturing (CMC) · Supplement 26AP
1982-04-15Manufacturing (CMC) · Supplement 25AP
1975-12-19OriginalAP
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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