APPLICATION
NDA010799
TYPE
NDA
ORIGINAL APPROVAL
1957-08-23
LATEST ACTION
1998-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE, TABLET
MARKETING STATUS
Discontinued
Products
DIMETANEDiscontinued
BROMPHENIRAMINE MALEATE 8MG · TABLET, EXTENDED RELEASE · ORAL
DIMETANEDiscontinued
BROMPHENIRAMINE MALEATE 12MG · TABLET, EXTENDED RELEASE · ORAL
DIMETANEDiscontinued
BROMPHENIRAMINE MALEATE 4MG · TABLET · ORAL
Approval history
1998-04-14Manufacturing (CMC) · Supplement 73 · standardAP
1996-04-30Labeling · Supplement 71 · standardAP
1996-02-06Manufacturing (CMC) · Supplement 70 · standardAP
1992-06-03Manufacturing (CMC) · Supplement 69 · standardAP
1989-01-24Manufacturing (CMC) · Supplement 68 · standardAP
1989-01-24Labeling · Supplement 67 · standardAP
1988-03-24Manufacturing (CMC) · Supplement 66 · standardAP
1988-03-17Manufacturing (CMC) · Supplement 65 · standardAP
1986-09-04Manufacturing (CMC) · Supplement 51 · standardAP
1986-07-10Manufacturing (CMC) · Supplement 52 · standardAP
1986-06-17Labeling · Supplement 64 · standardAP
1986-06-10Manufacturing (CMC) · Supplement 63 · standardAP
1985-06-24Manufacturing (CMC) · Supplement 60 · standardAP
1985-05-28Manufacturing (CMC) · Supplement 62 · standardAP
1984-12-19Manufacturing (CMC) · Supplement 58 · standardAP
1984-08-17Manufacturing (CMC) · Supplement 53 · standardAP
1984-08-17Manufacturing (CMC) · Supplement 59 · standardAP
1983-06-10Labeling · Supplement 35 · standardAP
1983-06-10Manufacturing (CMC) · Supplement 34 · standardAP
1983-04-15Efficacy · Supplement 57 · standardAP
1983-04-15Manufacturing (CMC) · Supplement 56 · standardAP
1957-08-23Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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