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FDA ANDA · ANDA088008

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA088008
TYPE
ANDA
ORIGINAL APPROVAL
1983-03-03
LATEST ACTION
2018-06-28
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEDiscontinued
HOMATROPINE METHYLBROMIDE 1.5MG/5ML, HYDROCODONE BITARTRATE 5MG/5ML · SYRUP · ORAL

Approval history

2018-06-28Labeling · Supplement 18 · standardAP
2017-01-13Labeling · Supplement 17 · standardAP
1996-05-10Labeling · Supplement 13AP
1996-02-13Manufacturing (CMC) · Supplement 14AP
1994-03-25Labeling · Supplement 12AP
1989-12-27Labeling · Supplement 11AP
1989-07-12Labeling · Supplement 10AP
1989-07-12Labeling · Supplement 9AP
1989-04-05Manufacturing (CMC) · Supplement 8AP
1988-10-20Labeling · Supplement 7AP
1988-07-28Manufacturing (CMC) · Supplement 6AP
1987-02-24Manufacturing (CMC) · Supplement 4AP
1987-02-24Manufacturing (CMC) · Supplement 5AP
1987-02-24Manufacturing (CMC) · Supplement 3AP
1986-12-05Manufacturing (CMC) · Supplement 2AP
1983-03-03OriginalAP
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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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