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FDA ANDA · ANDA207176

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Sponsor: AVANTHI INC

APPLICATION
ANDA207176
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-07
LATEST ACTION
2018-07-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATEPrescription
HOMATROPINE METHYLBROMIDE 1.5MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL

Approval history

2018-07-05Labeling · Supplement 1 · standardAP
2017-08-07UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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