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FDA ANDA · ANDA040295
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
Sponsor: ACTAVIS ELIZABETH
APPLICATION
ANDA040295
TYPE
ANDA
ORIGINAL APPROVAL
2000-12-01
LATEST ACTION
2018-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATEDiscontinued
HOMATROPINE METHYLBROMIDE 1.5MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
Approval history
2018-06-28Labeling · Supplement 9 · standardAP
2017-01-13Labeling · Supplement 8 · standardAP
2016-12-15Labeling · Supplement 7 · standardAP
2001-10-22Manufacturing (CMC) · Supplement 1AP
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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