APPLICATION
ANDA089116
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-22
LATEST ACTION
1999-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BROMPHERILDiscontinued
DEXBROMPHENIRAMINE MALEATE 6MG, PSEUDOEPHEDRINE SULFATE 120MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1999-06-17Manufacturing (CMC) · Supplement 12AP
1999-03-23Manufacturing (CMC) · Supplement 11AP
1996-05-31Manufacturing (CMC) · Supplement 10AP
1992-07-10Manufacturing (CMC) · Supplement 8AP
1992-01-15Manufacturing (CMC) · Supplement 6AP
1990-10-31Labeling · Supplement 7AP
1990-07-24Manufacturing (CMC) · Supplement 4AP
1990-07-24Labeling · Supplement 5AP
1990-07-24Manufacturing (CMC) · Supplement 3AP
1989-03-31Manufacturing (CMC) · Supplement 2AP
1988-03-04Manufacturing (CMC) · Supplement 1AP
1987-01-22OriginalAP
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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