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FDA ANDA · ANDA083821

BROMPHENIRAMINE MALEATE

Sponsor: WATSON LABS

APPLICATION
ANDA083821
TYPE
ANDA
ORIGINAL APPROVAL
1976-05-20
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

BROMPHENIRAMINE MALEATEDiscontinued
BROMPHENIRAMINE MALEATE 10MG/ML · INJECTABLE · INJECTION

Approval history

1999-02-19Manufacturing (CMC) · Supplement 24AP
1999-02-02Manufacturing (CMC) · Supplement 22AP
1996-12-04Manufacturing (CMC) · Supplement 21AP
1992-05-11Labeling · Supplement 20AP
1992-01-15Manufacturing (CMC) · Supplement 18AP
1991-07-23Labeling · Supplement 19AP
1991-02-22Manufacturing (CMC) · Supplement 14AP
1991-02-22Manufacturing (CMC) · Supplement 15AP
1991-01-07Labeling · Supplement 17AP
1990-07-31Labeling · Supplement 16AP
1989-05-09Labeling · Supplement 13AP
1988-10-05Manufacturing (CMC) · Supplement 12AP
1988-10-05Manufacturing (CMC) · Supplement 10AP
1988-10-05Manufacturing (CMC) · Supplement 11AP
1986-04-29Manufacturing (CMC) · Supplement 8AP
1985-02-08Manufacturing (CMC) · Supplement 5AP
1985-02-08Manufacturing (CMC) · Supplement 4AP
1984-02-13Manufacturing (CMC) · Supplement 7AP
1976-05-20OriginalAP
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