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FDA ANDA · ANDA040613

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Sponsor: GENUS LIFESCIENCES

APPLICATION
ANDA040613
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-08
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 10 · standardAP
2017-01-13Labeling · Supplement 9 · standardAP
2016-12-15Labeling · Supplement 8 · standardAP
2008-02-08OriginalAP
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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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