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FDA ANDA · ANDA205731
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Sponsor: PADAGIS US
APPLICATION
ANDA205731
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-15
LATEST ACTION
2025-05-14
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
2025-05-14Labeling · Supplement 3 · standardAP
2025-05-14Labeling · Supplement 4 · standardAP
2018-06-28Labeling · Supplement 2 · standardAP
2017-02-15UNKNOWN · Original · standardAP
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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