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FDA ANDA · ANDA206952

HYDROCODONE BITARTRATE

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA206952
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

HYDROCODONE BITARTRATENone (Tentative Approval)
HYDROCODONE BITARTRATE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
HYDROCODONE BITARTRATENone (Tentative Approval)
HYDROCODONE BITARTRATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2017-04-05UNKNOWN · Original · standardTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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