APPLICATION
NDA013483
TYPE
NDA
ORIGINAL APPROVAL
1963-10-18
LATEST ACTION
2005-03-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DISOPHROLDiscontinued
DEXBROMPHENIRAMINE MALEATE 6MG, PSEUDOEPHEDRINE SULFATE 120MG · TABLET, EXTENDED RELEASE · ORAL
DRIXORAL · ReferenceDiscontinued
DEXBROMPHENIRAMINE MALEATE 6MG, PSEUDOEPHEDRINE SULFATE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
Approval history
2001-07-11Manufacturing (CMC) · Supplement 38 · standardAP
2001-06-29Manufacturing (CMC) · Supplement 39 · standardAP
2001-03-06Manufacturing (CMC) · Supplement 37 · standardAP
2001-01-24Manufacturing (CMC) · Supplement 35 · standardAP
2000-10-17Manufacturing (CMC) · Supplement 36 · standardAP
2000-04-18Manufacturing (CMC) · Supplement 34 · standardAP
1998-11-18Manufacturing (CMC) · Supplement 31 · standardAP
1998-10-06Manufacturing (CMC) · Supplement 33 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 32 · standardAP
1989-01-24Manufacturing (CMC) · Supplement 28 · standardAP
1986-07-08Manufacturing (CMC) · Supplement 27 · standardAP
1986-02-22Manufacturing (CMC) · Supplement 22 · standardAP
1985-03-20Manufacturing (CMC) · Supplement 20 · standardAP
1984-09-21Manufacturing (CMC) · Supplement 21 · standardAP
1984-09-18Manufacturing (CMC) · Supplement 24 · standardAP
1982-09-13Manufacturing (CMC) · Supplement 16 · standardAP
1982-09-13REMS · Supplement 17 · standardAP
1982-07-01Manufacturing (CMC) · Supplement 19 · standardAP
1981-09-11Labeling · Supplement 15AP
1980-07-21Labeling · Supplement 14AP
1980-06-13Manufacturing (CMC) · Supplement 13 · standardAP
1980-05-07Manufacturing (CMC) · Supplement 12 · standardAP
1978-10-02Manufacturing (CMC) · Supplement 11 · standardAP
1978-08-14Manufacturing (CMC) · Supplement 9 · standardAP
1978-05-15Manufacturing (CMC) · Supplement 10 · standardAP
1976-08-30Manufacturing (CMC) · Supplement 8 · standardAP
1963-10-18Type 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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