APPLICATION
ANDA088508
TYPE
ANDA
ORIGINAL APPROVAL
1985-07-30
LATEST ACTION
2018-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TUSSIGONDiscontinued
HOMATROPINE METHYLBROMIDE 1.5MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
Approval history
2018-06-28Labeling · Supplement 19 · standardAP
2018-06-28Labeling · Supplement 21 · standardAP
2018-06-28Labeling · Supplement 20 · standardAP
2017-01-13Labeling · Supplement 18 · standardAP
2016-12-15Labeling · Supplement 17 · standardAP
1994-11-22Manufacturing (CMC) · Supplement 8AP
1993-04-15Labeling · Supplement 7AP
1992-12-15Labeling · Supplement 6AP
1991-01-23Manufacturing (CMC) · Supplement 5AP
1989-11-06Manufacturing (CMC) · Supplement 3AP
1989-11-06Manufacturing (CMC) · Supplement 4AP
1989-11-06Labeling · Supplement 2AP
1989-03-31Manufacturing (CMC) · Supplement 1AP
1985-07-30OriginalAP
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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