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FDA ANDA · ANDA076023

HYDROCODONE BITARTRATE AND IBUPROFEN

Sponsor: TEVA

APPLICATION
ANDA076023
TYPE
ANDA
ORIGINAL APPROVAL
2003-04-11
LATEST ACTION
2018-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND IBUPROFENDiscontinued
HYDROCODONE BITARTRATE 7.5MG, IBUPROFEN 200MG · TABLET · ORAL

Approval history

2018-09-20Labeling · Supplement 18 · standardAP
2018-09-18REMS · Supplement 19AP
2018-08-30Labeling · Supplement 17 · standardAP
2007-04-30Labeling · Supplement 8AP
2007-04-30Labeling · Supplement 6AP
2003-04-11OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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