APPLICATION
NDA007638
TYPE
NDA
ORIGINAL APPROVAL
1950-08-15
LATEST ACTION
2015-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CHLOR-TRIMETON · ReferenceDiscontinued
CHLORPHENIRAMINE MALEATE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
CHLOR-TRIMETON · ReferenceDiscontinued
CHLORPHENIRAMINE MALEATE 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
Approval history
2002-03-06Manufacturing (CMC) · Supplement 29 · standardAP
2001-01-26Manufacturing (CMC) · Supplement 28 · standardAP
2000-05-19Manufacturing (CMC) · Supplement 27 · standardAP
1998-11-17Manufacturing (CMC) · Supplement 25 · standardAP
1997-10-20Labeling · Supplement 24 · standardAP
1986-07-08Manufacturing (CMC) · Supplement 23 · standardAP
1986-01-30Labeling · Supplement 18AP
1986-01-30Efficacy · Supplement 22AP
1984-09-18Manufacturing (CMC) · Supplement 21 · standardAP
1983-02-18Manufacturing (CMC) · Supplement 17 · standardAP
1983-01-04Labeling · Supplement 16AP
1982-08-30Manufacturing (CMC) · Supplement 15 · standardAP
1982-05-07Efficacy · Supplement 13AP
1981-10-30Labeling · Supplement 12AP
1980-07-30Manufacturing (CMC) · Supplement 10 · standardAP
1980-07-03Manufacturing (CMC) · Supplement 9 · standardAP
1980-06-11Manufacturing (CMC) · Supplement 11 · standardAP
1980-02-01Manufacturing (CMC) · Supplement 8 · standardAP
1979-12-20Labeling · Supplement 7AP
1979-01-05Manufacturing (CMC) · Supplement 6 · standardAP
1978-10-18Labeling · Supplement 2AP
1950-08-15Type 3 - New Dosage Form · 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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