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FDA ANDA · ANDA203535

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Sponsor: NOVEL LABS INC

APPLICATION
ANDA203535
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-13
LATEST ACTION
2024-10-31
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

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

Approval history

2024-10-31REMS · Supplement 5AP
2018-06-28Labeling · Supplement 2 · standardAP
2017-02-13UNKNOWN · OriginalAP
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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